Obesity (BMI>30)NutrImmuneNCT07850206
NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity
A study testing Mixed test meal, Biological sampling and Questionnaires in people with Obesity (BMI>30) and Immune Abnormalities, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in 3 countries.
Trial summary
Obesity is a complex health condition defined by the World Health Organization (WHO) as an excess of body weight that may be harmful to health. It leads to other diseases such as type 2 diabetes or cardiovascular diseases, commonly referred to as "co-morbidities." Among these, it is known that obesity increases the… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Obesity (BMI>30), Immune Abnormalities, Low-grade Inflammation
- What is being tested?
- Mixed test meal, Biological sampling and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Oct 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30≤BMI<40 kg/m2
- Waist circumference ≥80 cm for women and ≥94 cm for men
- Low-grade inflammatory status, defined as:
- High-sensitive CRP (hsCRP) ≥ 3 mg/L
- Low diet quality: E-DII > 0, indicating a pro-inflammatory dietary potential
- Affiliation with a social security scheme or beneficiary of such a scheme;
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- Effective contraception for women with ability to have children
- Stable weight for at least 3 months (+/- 5% of total body weight)
- In the opinion of the investigator, the subject has adequate support to comply with the entire study requirements as described in the protocol (i.e. ability to move to and from trial site, to understand and fill in the questionnaires, use the app; attend the scheduled visits, full understanding of the protocol)
- Do not follow an exclusive diet (i.e. vegan, vegetarian, or diet without gluten or lactose)
- Living at maximum 1 hour from clinical trial site
- Willingness to not change physical activity level for the whole duration of the study.
- Willingness not to perform any other weight-loss approaches.
- Agreement to adhere to Lifestyle Considerations throughout study duration
- For women of childbearing potential, a negative urinary pregnancy test is required
- General non-inclusion criteria:
- Persons subject to a safeguard of justice measure
- Persons without valid health certificate(s) in case of governmental measures in exceptional epidemic situations
- Persons under legal protection (guardianship, curatorship)
- Persons unable to use the study applications after a brief introduction or no access to a mobile phone or tablet with Bluetooth and internet access;
- Persons with devices with previous iOS or Android operating systems that cannot run the applications, given that use of the IPICS-app (TOUVA) is necessary for the study;
- Persons without a freezer and/or reluctant to store biological samples inside;
- Tobacco (or vaping equivalent) consumption > 5 cigarettes per day.
- Pregnancy or breastfeeding in women of childbearing potential
- Alcohol consumption exceeding 30g alcohol/day
- Claustrophobia for indirect calorimetry.
- Needle or blood phobia
- Medical non-inclusion criteria:
- Usage in past 3 months : Antibiotics, Probiotics, Prebiotics, Systemic corticosteroids, Immunosuppressives
- Laxative usage in past 2 months
- PPI (Proton pomp inhibitor) usage in past 2 days
- Conditions that alter both inflammatory and immune profile and induce biases in results interpretation
- Uncontrolled thyroid disease, history of musculoskeletal, autoimmune, or neurological disease, as well as abnormal kidney and liver function tests (>2 times upper reference range limit)
- Presence of active chronic inflammatory disease, autoimmune disease requiring immunomodulatory treatment, known immunodeficiency, active malignancy, active chronic infection, or ongoing immunosuppressive treatment likely to significantly alter the immune parameters under investigation.
- Presence of type 2 diabetes or uncontrolled cardiovascular disease (Stable obesity-related comorbidities, including hypertension, dyslipidemia, and stable cardiovascular disease, are not considered exclusion criteria).
- Major mental disorders
- Severe eating disorders based on detailed medical history, clinical examination and expertise of the investigating physician, trained in nutrition.
- The use of medication or physical conditions interfering with the study outcomes, at the discretion of the investigating physician
- Infectious episode in the month prior to inclusion
- Allergy or intolerance to any of the components of the study devices and products
- No contraindications to taking oral nutritional supplements, such as severe swallowing disorders or impaired consciousness, and non-functional digestive tract
Who cannot join
- Health conditions or treatments interfering with the protocol outcomes or procedure, depending on the situation, postponement of visits may be considered at the discretion of the physicians investigators;
- Withdrawal of consent
- Appearance of a non-inclusion criterion; depending on the situation, postponement of visits may be considered at the discretion of the investigating physicians;
- Lost to follow-up
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
France2 sites
Hospices Civils de Lyon et Centre de Recherche en Nutrition Humaine Rhône-Alpes
Lyon, 69002
Julie-Anne NAZARE, + 33478863994, julie-anne.nazare@univ-lyon1.fr
Louise SECONDA, +33478863994, louise.seconda@univ-lyon1.fr
Clinical Investigation Center Pitié-Paris Est and Nutrition dpt. Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris
Paris, 75013
Fabienne DELESTRE, PhD, 33142177031, fabienne.delestre@aphp.fr
Pierre Bel Lassen, MD,PhD, pierre.bellassen@aphp.fr
Germany1 site
University of Hohenheim
Stuttgart, 70599
Benjamin Seethaler, +49 711 459 24102, b.seethaler@uni-hohenheim.de
Stephan Bischoff
Netherlands1 site
Amsterdam UMC
Amsterdam, 1105 AZ
Midas Van den Tweel, +3120 5667050, m.vandentweel@amsterdamumc.nl
Max Nieuwdorp
About this study
Official title: NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity - a Randomized Controlled Study
Obesity is a complex health condition defined by the World Health Organization (WHO) as an excess of body weight that may be harmful to health. It leads to other diseases such as type 2 diabetes or cardiovascular diseases, commonly referred to as "co-morbidities." Among these, it is known that obesity increases the risk of developing infectious diseases and of these diseases progressing to severe stages.
During the COVID-19 pandemic and the 2009 H1N1 influenza epidemic, a rise in severe infection cases was observed in people with obesity. A part of people with obesity exhibits certain markers on the surface of their immune cells, which are known to cause immunosuppression when present in high numbers, thus increasing the risk of developing infectious diseases.
Read more
Investigator teams found that after bariatric surgery and a calorie-restricted diet for weight loss, patients with obesity can improve the levels of these immunity-related markers. Moreover, the choice of foods consumed contributes to strengthening the immune system and immune functions of individuals, both directly by influencing inflammation and indirectly through the microbiota. However, to date, there are no dietary recommendations specifically designed to help people with obesity improve their immune response.
Therefore, this study aims to compare different dietary recommendations intended to improve immune status, with or without calorie restriction, during 3 months, in individuals with obesity (BMI ≥ 30 kg/m²) and impaired immunity. Over 6 months (3 months of nutritional intervention and 3 months of follow-up), investigators will collect extensive information through biological samples, measurements and questionnaires to compare the different dietary interventions studied and to understand the mechanisms behind the results obtained.
Read the detailed description
Beyond its metabolic consequences, obesity is associated with an increased risk of severe infectious diseases. Indeed, Obesity would be associated with immune remodeling, reduced microbial diversity, gut barrier dysfunction, and increased pro-inflammatory microbial species. These alterations can promote systemic inflammation and metabolic endotoxemia. Moreover, immune checkpoints, including the PD-1/PD-L1 pathway, are important regulators of immune responses and may also contribute to immune dysregulation in obesity.
Diet represents an important modulator of inflammation and immunity. The microbiome and the glycome may further mediate the effects of diet on immune function. Changes in microbial composition and host glycosylation can influence immune signaling and the activity of immune checkpoints.
Overall, the diet-microbiome-glycome axis may represent a key determinant of immune homeostasis in obesity. However, the effects of specific diets and nutrients on immune checkpoints remain insufficiently understood and require further clinical investigation.
In this clinical study, the investigator teams hypothesize that a nutritional intervention based on personalized dietary recommendations will improve the responses of markers associated with immunity (reduction in CD4+ cells and in the expression of immune checkpoint proteins on T cells, particularly PD-1) in individuals with obesity. The effects on immunity are thought to be mediated by changes in the gut microbiota and potentially by the immunoglycome, which should simultaneously lead to improvements in cardiometabolic health markers. These markers will also be monitored during this study.
The Nutrimmune clinical study is a controlled, randomized, open-label, parallel-group (3-arm), multicenter.
The investigators will recruit 168 volunteers (men or women) with moderate obesity (BMI between 30 and 40 kg/m²), aged 40 to 70 and at immune and metabolic inflammatory risk (hsCRP above 3 mg/L and dietary inflammatory index (E-DII)>0).
The intervention will consist of providing personalized nutritional advice through an app (called TOUVA developed by a private collaborator), which will offer participants appropriate meal plans each week. The nutritional advice will depend on the study arm to which the participant has been randomized.
Three nutritional interventions will be tested in parallel in this study:
- The Balanced-Immunity diet with calorie restriction (BI-CR),
- The Balanced-Immunity diet without calorie restriction (BI),
- The standard diet with calorie restriction (STD-CR)
During the study, participants will be seen for the first time during a screening visit, followed by three metabolic assessment visits: before starting the intervention, at 3 months into the nutritional intervention, and 3 months after the end of the intervention.
The primary endpoint will be the change in the percentage of CD4⁺ T cells expressing the immune checkpoint protein (ICP) PD-1 in PBMCs, measured from baseline to 3 months (end of the nutritional intervention).
The secondary endpoints included : immune and inflammatory phenotypes, microbiome and molecular mechanisms, cardiometabolic and physiological parameters, lifestyle and eating behaviour chang and acceptability, adherence and usability to the nutritional intervention.
This study would help advance scientific understanding of how dietary and personalized interventions can help improve markers associated with immunity in people with obesity and impaired immunity. In the public health goal to improve the care of people with obesity and impaired immunity.
- Being tested
- Mixed test meal, Biological sampling, Questionnaires, Caloric restriction, Balanced-immunity diet
- Keywords
- Obesity, Immune checkpoint expression, balanced diet, caloric restriction, low-grade inflammation, Microbiome, Glyco-immunomic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed test mealOther
A mixed test meal, rich in glucose and lipids will be served to the participant during baseline, 3 months and 6 months visits. The participant will have 10 minutes to eat it, and then blood will be sampled during the 4 hours following ingestion of the meal-test. The test meal must be consumed within 10 minutes in order to ensure standardized ingestion conditions between individuals and to limit biases linked to different ingestion times, which could subsequently alter the kinetics of biomarkers measured following meal ingestion. This will allow us to describe the postprandial excursions in glucose, triglycerides and insulin with indicators of the curve as amplitude, pick or time to return to baseline. These indicators are early markers of cardio-metabolic risk alterations. A biobanking of samples is also performed.
Biological samplingBiological
Changes in biological parameters will be assessed based on samples collected before the baseline, 3-month and 6-month visits (maximum 2 days before each visit) for feces, and during visits for blood and adipose tissue.
QuestionnairesBehavioural
In order to assess some of the secondary outcomes, participants will be asked to fill in the following questionnaires : 3 24h-recall and validated Food Frequency questionnaire (FFQ), TEFQ, Baecke, Bristol, GSRS, SF12, IWQOL, PSS, PHQ-9, GSES, PSQI, MAUQ and CSQ-8.
Caloric restrictionOther
Participants will be placed on a calorie-restricted diet with a reduction of 500 kcal/day (calculated based on total energy requirement) during 3 months. The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake will remain unchanged.
Balanced-immunity dietOther
The intervention consists of delivering the diet previously defined as the "Balanced-Immunity" diet in the form of meal plan and menus, accessible via TOUVA, a dedicated application during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Balanced-Immunity without caloric restriction | Experimental | The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake. Receives: Other: Mixed test meal; Biological: Biological sampling; Behavioral: Questionnaires; Other: Balanced-immunity diet |
| Balanced-Immunity with caloric restriction | Experimental | Description: The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) with a caloric restriction of 500 kcal/days (based on the evaluation of total energy requirements), each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake. Receives: Other: Mixed test meal; Biological: Biological sampling; Behavioral: Questionnaires; Other: Caloric restriction; Other: Balanced-immunity diet |
| Standard diet with caloric restriction | Experimental | The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans, according to their needs, food preferences and usual food habits, each week during 3 months. The generated menu has a reduction of 500 kcal/day (based on the evaluation of total energy requirements). The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake should remain unchanged. Receives: Other: Mixed test meal; Biological: Biological sampling; Behavioral: Questionnaires; Other: Caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention
The first endpoint will be evaluated by calculating the change (Δ) in the percentage of PD-1⁺ CD4⁺ T cells between baseline and month 3 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry to quantify the percentage of PD-1⁺ CD4⁺ T cells.
Measured: Baseline and 3-months (after the nutritional intervention)
Secondary outcomes (49)
Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention and 3 month of follow-up
The endpoint will be evaluated by calculating the change (Δ) in the percentage of PD-1⁺ CD4⁺ T cells between baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry to quantify the percentage of PD-1⁺ CD4⁺ T cells.
Measured: Baseline and 6 months (after 3 months of nutritional intervention and 3 months of follow-up)
Comparison of immune cell phenotyping at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions
The endpoint will be evaluated by calculating the change (Δ) in cell phenotyping between baseline and month 3, baseline and month 6 and month 3 and month 6 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow and mass cytometry.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of immune checkpoint proteins at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions
The endpoint will be evaluated by calculating the change (Δ) in immune checkpoint proteins between baseline and month 3 and baseline and month 6 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry and mass cytometry
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of concentration of immunoglobulines G (IgG) in serum at baseline, month 3 and month 6 between the nutritional interventions
The endpoint will be evaluated by calculating the change (Δ) in the concentration of Immunoglobulines G in serum between baseline and month 3 and baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of cytokines and hsCRP at baseline, month 3 and month 6 in serum between the nutritional interventions
The endpoint will be evaluated by calculating the change (Δ) in the concentration of cytokines by Olink-multi-immune/inflammatory markers and hsCRP, between baseline and month 3 and baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of the ratio immunoglobulines A fecal/ immunoglobulines G fecal at baseline, month 3 and month 6 between the nutritional interventions
The endpoint will be evaluated by calculating the change (Δ) in the ratio IgA/IgG fecal by IgA and IgG binding pattern for microbiota between baseline and month 3 and baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of low-grade inflammation and immune-profile at baseline, month 3 and month 6 between the nutritional interventions
The endpoint will be evaluated by multiplex profiling of more than 750 circulating inflammatory and organ-specific proteins (Olink exploratory panels). Group comparisons will be based on the changes in the profile (Δ values) to determine the effect of each nutritional intervention.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of proteomics signatures linked to immune and organ-specific proteins at baseline, month 3 and month 6 between the nutritional interventions
The endpoint will be evaluated by multiplex profiling of more than 750 circulating inflammatory and organ-specific proteins (Olink exploratory panels). Group comparisons will be based on the changes in the profile (Δ values) to determine the effect of each nutritional intervention.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of glyco-immune checkpoint profile at baseline, month 3 and month 6 between the nutritional interventions
The glyco-immune checkpoint profiling in blood, PBMCs and adipose tissue will be evaluated with glycan technology and next-generation SUGAR-seq technology.
Group comparisons will be based on the changes in the profile (Δ values) to determine the effect of each nutritional intervention.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of antigen stimulation and serology at baseline, month 3 and month 6 between the nutritional interventions
The outcome will be assessed from PBMC with co-culture test with CSA and nutriments in a subsample of participants from Lyon site. The following parameters will be studied: markers of helper and cytotoxic T-cell functions
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of gut microbiota composition, diversity and functional capacity at baseline, month 3 and month 6 between the nutritional interventions
Metagenomics will be performed by shotgun at baseline, month 3 and month 6 to assess and compare the nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of gut barrier integrity at baseline, month 3 and month 6 between the nutritional interventions
Gut barrier integrity will be assessed by the concentration of plasma lipopolysaccharide-binding protein (LBP) in plasma at baseline, month 3 and month 6 to assess and compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of gut permeability (fecal zonulin) at baseline, month 3 and month 6 between the nutritional interventions
Gut permability will be assessed by the concentration of fecal zonulin at baseline, month 3 and month 6 to assess and compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of short-chain fatty acids (SCFAs) profil at baseline, month 3 and month 6 between the nutritional interventions
SCFAs profil will be assessed by CGMS in plasma and in feces at baseline, month 3 and month 6 to assess and compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of metabolomics profil at baseline, month 3 and month 6 between the nutritional interventions
Target metabolomics will be done in plasma at baseline, month 3 and month 6 to assess metabolomics profil and compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of fecal pH at baseline, month 3 and month 6 between the nutritional interventions
Fecal pH will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Blood pressure at baseline, month 3 and month 6 between the nutritional interventions
Blood presure will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Resting heart rate at baseline, month 3 and month 6 between the nutritional interventions
Resting heart rate will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Body mass index at baseline, month 3 and month 6 between the nutritional interventions
Body mass index will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Waist circumferences, hip circumferences and waist/hip ratio at baseline, month 3 and month 6 between the nutritional interventions
Waist circumferences, hip circumferences and waist/hip ratio will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Body composition at baseline, month 3 and month 6 between the nutritional interventions
Body composition (lean and fat mass) will be assessed by bio-impedancemetry at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Energy metabolism at baseline, month 3 and month 6 between the nutritional interventions
Energy metabolism (Resting Metabolic Rate) will be assessed by indirect calorimetry at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Glycemia fasting at baseline, month 3 and month 6 between the nutritional interventions
Glycemia fasting will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Insulin fasting at baseline, month 3 and month 6 between the nutritional interventions
Insulin fasting will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Insulin resistance at baseline, month 3 and month 6 between the nutritional interventions
Insulin resistance will be assessed with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Lipid profile fasting at baseline, month 3 and month 6 between the nutritional interventions
Lipid profile including: cholesterol, LDL, HDL, trigycerides, non-esterified fatty acids, and ApoB fasting will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Fatty acid profile at baseline, month 3 and month 6 between the nutritional interventions
Fatty acid profile will be assessed in adipose tissue at baseline, month 3 and month 6 to compare the three nutritional interventions in a subsample included in Lyon.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Liver health at baseline, month 3 and month 6 between the nutritional interventions
Liver health will be assessed with the level in plasma of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyl transferase (GGT) :at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Appetite-regulating hormones at baseline, month 3 and month 6 between the nutritional interventions
Level of adiponectin and leptin fasting hormones will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Glucose kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions
Glycemia will be assessed at t-30, t0, t15, t30, t45, t60, t90, t120, t180 and t240. The followings indicators will be calculated: maximum, minimum, times at peak or nadir, total and incremental AUCs (0-120, 120-240 and 0-240 min) during the postprandial period (meal-test).
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Insulin kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions
Insulin will be assessed at t-30, t0, t15, t30, t45, t60, t90, t120, t180 and t240. The followings indicators will be calculated: maximum, minimum, times at peak or nadir, total and incremental AUCs (0-120, 120-240 and 0-240 min) during the postprandial period (meal-test).
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Triglycerides kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions
Triglycerides will be assessed at t-30, t0, t60, t120 and t240. The followings indicators will be calculated: maximum, minimum, times at peak or nadir, total and incremental AUCs (0-120, 120-240 and 0-240 min) during the postprandial period (meal-test).
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Dietary intake of food groups at baseline, month 3 and month 6 between the nutritional interventions
Main food groups consumption will be assessed with 3 days of dietary records and validated Food Frequency Questionnaire (FFQ) filled in at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Daily mean of calorie, macronutriment and micronutriments intakes at baseline, month 3 and month 6 between the nutritional interventions
Daily mean of calorie, macronutriment and micronutriments intakes will be assessed with 3 days of dietary records and validated Food Frequency Questionnaire (FFQ) filled in at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Indexes of diet quality at baseline, month 3 and month 6 between the nutritional interventions
The Energy-adjusted Dietary Inflammatory Index (E-DII), alternative Healthy Eating Index (AHEI) and Dietary Approches to Stop Hypertension (DASH) will be assessed with a validated Food Frequency Questionnaire (FFQ) filled in at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of eating behaviour at baseline, month 3 and month 6 between the nutritional interventions
Modification of eating behaviour will be assessed with the three-factor eating questionnaire 21 (TFEQ-21), filled in at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of eating behaviour at baseline, month 3 and month 6 between the nutritional interventions
Modification of appetite will be assessed with visual analogue scales to range hunger, fullness and satiety fasting and at the end of meal test, at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of gastrointestinal tolerance at baseline, month 3 and month 6 between the nutritional interventions
Modification of gastrointestinal tolerance will be assessed with Bristol Stool Scale at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of gastrointestinal symptom at baseline, month 3 and month 6 between the nutritional interventions
Modification of gastrointestinal symptome will be assessed with the Gastrointestinal Symptom Rating Scale (GSRS) at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of quality of life at baseline, month 3 and month 6 between the nutritional interventions
Modification of quality of life will be assessed with the General quality of life questionnaire (SF-12) at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of impact of weight on quality of life at baseline, month 3 and month 6 between the nutritional interventions
Modification of impact of weight on quality of life will be assessed with the Impact of Weight on quality of Life (IWQOL) questionnaire at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of perceived stress at baseline, month 3 and month 6 between the nutritional interventions
Modification of perceived stress will be assessed with the Perceived Stress Scale (PSS) at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of self-efficacy at baseline, month 3 and month 6 between the nutritional interventions
Modification of self-efficacy will be assessed with general Stress-efficacy scale (GSES) at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of depresion symptoms at baseline, month 3 and month 6 between the nutritional interventions
Modification of depression symptoms will be assessed with Patient Health Questionnaire (PHQ-9) at baseline, month 3 and month 6.
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Physical activity and sedentary behavior at baseline, month 3 and month 6 between the nutritional interventions
Physical activity and sedentary behavior will be assessed by Baecke Physical Activity Questionnaire at baseline, month 3 and month 6
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Sleep duration and quality at baseline, month 3 and month 6 between the nutritional interventions
Sleep duration and quality will be assessed by Pittsburgh Sleep Quality Index (PSQI) at baseline, month 3 and month 6
Measured: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Acceptability of the nutritional intervention by the application
Aceptability of the nutritional intervention by the application will be asses with the Client Satisfaction Questionnaire (CSQ-8), at the end of the intervention (month 3)
Measured: After 3 month of nutritional intervention
Integration of the meal plan into daily life
Integration of the meal plan into daily life will be assessed with custom Likert-scale items daily during the intervention
Measured: Between 1) baseline and month 3 (after the nutritional intervention)
Usuability to the nutritional intervention by the application
Usuability and user-friendliness of the mobile application will be assessed using the mHealth App Usability Questionnaire (MAUQ)
Measured: At the end of nutritional intervention (month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a controlled, randomized, open-label, parallel-group (3-arm), multicenter clinical study
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Amsterdam UMC, location VUmc, University of Hohenheim, University of Bern, Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute, Integrative Phenomics, Sorbonne University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850206
- Sponsor's protocol ID
- C25-106
- Acronym
- NutrImmune
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision will be taken depending on local regulation at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07850206
- Acronym / sponsor ID
- NutrImmune / C25-106
- Keywords
- Obesity, Immune checkpoint expression, balanced diet, caloric restriction, low-grade inflammation, Microbiome, Glyco-immunomic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Amsterdam UMC, location VUmc, University of Hohenheim, University of Bern, Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute, Integrative Phenomics, Sorbonne University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a complex health condition defined by the World Health Organization (WHO) as an excess of body weight that may be harmful to health. It leads to other diseases such as type 2 diabetes or cardiovascular diseases, commonly referred to as "co-morbidities." Among these, it is known that obesity increases the risk of developing infectious diseases and of these diseases progressing to severe stages.
During the COVID-19 pandemic and the 2009 H1N1 influenza epidemic, a rise in severe infection cases was observed in people with obesity. A part of people with obesity exhibits certain markers on the surface of their immune cells, which are known to cause immunosuppression when present in high numbers, thus increasing the risk of developing infectious diseases.
Investigator teams found that after bariatric surgery and a calorie-restricted diet for weight loss, patients with obesity can improve the levels of these immunity-related markers. Moreover, the choice of foods consumed contributes to strengthening the immune system and immune functions of individuals, both directly by influencing inflammation and indirectly through the microbiota. However, to date, there are no dietary recommendations specifically designed to help people with obesity improve their immune response.
Therefore, this study aims to compare different dietary recommendations intended to improve immune status, with or without calorie restriction, during 3 months, in individuals with obesity (BMI ≥ 30 kg/m²) and impaired immunity. Over 6 months (3 months of nutritional intervention and 3 months of follow-up), investigators will collect extensive information through biological samples, measurements and questionnaires to compare the different dietary interventions studied and to understand the mechanisms behind the results obtained.
Detailed description
Beyond its metabolic consequences, obesity is associated with an increased risk of severe infectious diseases. Indeed, Obesity would be associated with immune remodeling, reduced microbial diversity, gut barrier dysfunction, and increased pro-inflammatory microbial species. These alterations can promote systemic inflammation and metabolic endotoxemia. Moreover, immune checkpoints, including the PD-1/PD-L1 pathway, are important regulators of immune responses and may also contribute to immune dysregulation in obesity.
Diet represents an important modulator of inflammation and immunity. The microbiome and the glycome may further mediate the effects of diet on immune function. Changes in microbial composition and host glycosylation can influence immune signaling and the activity of immune checkpoints.
Overall, the diet-microbiome-glycome axis may represent a key determinant of immune homeostasis in obesity. However, the effects of specific diets and nutrients on immune checkpoints remain insufficiently understood and require further clinical investigation.
In this clinical study, the investigator teams hypothesize that a nutritional intervention based on personalized dietary recommendations will improve the responses of markers associated with immunity (reduction in CD4+ cells and in the expression of immune checkpoint proteins on T cells, particularly PD-1) in individuals with obesity. The effects on immunity are thought to be mediated by changes in the gut microbiota and potentially by the immunoglycome, which should simultaneously lead to improvements in cardiometabolic health markers. These markers will also be monitored during this study.
The Nutrimmune clinical study is a controlled, randomized, open-label, parallel-group (3-arm), multicenter.
The investigators will recruit 168 volunteers (men or women) with moderate obesity (BMI between 30 and 40 kg/m²), aged 40 to 70 and at immune and metabolic inflammatory risk (hsCRP above 3 mg/L and dietary inflammatory index (E-DII)>0).
The intervention will consist of providing personalized nutritional advice through an app (called TOUVA developed by a private collaborator), which will offer participants appropriate meal plans each week. The nutritional advice will depend on the study arm to which the participant has been randomized.
Three nutritional interventions will be tested in parallel in this study:
- The Balanced-Immunity diet with calorie restriction (BI-CR),
- The Balanced-Immunity diet without calorie restriction (BI),
- The standard diet with calorie restriction (STD-CR)
During the study, participants will be seen for the first time during a screening visit, followed by three metabolic assessment visits: before starting the intervention, at 3 months into the nutritional intervention, and 3 months after the end of the intervention.
The primary endpoint will be the change in the percentage of CD4⁺ T cells expressing the immune checkpoint protein (ICP) PD-1 in PBMCs, measured from baseline to 3 months (end of the nutritional intervention).
The secondary endpoints included : immune and inflammatory phenotypes, microbiome and molecular mechanisms, cardiometabolic and physiological parameters, lifestyle and eating behaviour chang and acceptability, adherence and usability to the nutritional intervention.
This study would help advance scientific understanding of how dietary and personalized interventions can help improve markers associated with immunity in people with obesity and impaired immunity. In the public health goal to improve the care of people with obesity and impaired immunity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a controlled, randomized, open-label, parallel-group (3-arm), multicenter clinical study
| Arm | Type | Receives |
|---|---|---|
| Balanced-Immunity without caloric restriction | Experimental | Other: Mixed test meal, Biological: Biological sampling, Behavioral: Questionnaires, Other: Balanced-immunity dietThe intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake. |
| Balanced-Immunity with caloric restriction | Experimental | Other: Mixed test meal, Biological: Biological sampling, Behavioral: Questionnaires, Other: Caloric restriction, Other: Balanced-immunity dietDescription: The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) with a caloric restriction of 500 kcal/days (based on the evaluation of total energy requirements), each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake. |
| Standard diet with caloric restriction | Experimental | Other: Mixed test meal, Biological: Biological sampling, Behavioral: Questionnaires, Other: Caloric restrictionThe intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans, according to their needs, food preferences and usual food habits, each week during 3 months. The generated menu has a reduction of 500 kcal/day (based on the evaluation of total energy requirements). The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake should remain unchanged. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- 30≤BMI<40 kg/m2
- Waist circumference ≥80 cm for women and ≥94 cm for men
- Low-grade inflammatory status, defined as:
- Affiliation with a social security scheme or beneficiary of such a scheme;
- Effective contraception for women with ability to have children
Key exclusion criteria (4 listed)
- Health conditions or treatments interfering with the protocol outcomes or procedure, depending on the situation, postponement of visits may be considered at the discretion of the physicians investigators;
- Withdrawal of consent
- Appearance of a non-inclusion criterion; depending on the situation, postponement of visits may be considered at the discretion of the investigating physicians;
- Lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed test mealA mixed test meal, rich in glucose and lipids will be served to the participant during baseline, 3 months and 6 months visits. The participant will have 10 minutes to eat it, and then blood will be sampled during the 4 hours following ingestion of the meal-test. The test meal must be consumed within 10 minutes in order to ensure standardized ingestion conditions between individuals and to limit biases linked to different ingestion times, which could subsequently alter the kinetics of biomarkers measured following meal ingestion. This will allow us to describe the postprandial excursions in glucose, triglycerides and insulin with indicators of the curve as amplitude, pick or time to return to baseline. These indicators are early markers of cardio-metabolic risk alterations. A biobanking of samples is also performed. | Other | Balanced-Immunity with caloric restriction, Balanced-Immunity without caloric restriction, Standard diet with caloric restriction |
| Biological samplingChanges in biological parameters will be assessed based on samples collected before the baseline, 3-month and 6-month visits (maximum 2 days before each visit) for feces, and during visits for blood and adipose tissue. | Biological | Balanced-Immunity with caloric restriction, Balanced-Immunity without caloric restriction, Standard diet with caloric restriction |
| QuestionnairesIn order to assess some of the secondary outcomes, participants will be asked to fill in the following questionnaires : 3 24h-recall and validated Food Frequency questionnaire (FFQ), TEFQ, Baecke, Bristol, GSRS, SF12, IWQOL, PSS, PHQ-9, GSES, PSQI, MAUQ and CSQ-8. | Behavioural | Balanced-Immunity with caloric restriction, Balanced-Immunity without caloric restriction, Standard diet with caloric restriction |
| Caloric restrictionParticipants will be placed on a calorie-restricted diet with a reduction of 500 kcal/day (calculated based on total energy requirement) during 3 months. The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake will remain unchanged. | Other | Balanced-Immunity with caloric restriction, Standard diet with caloric restriction |
| Balanced-immunity dietThe intervention consists of delivering the diet previously defined as the "Balanced-Immunity" diet in the form of meal plan and menus, accessible via TOUVA, a dedicated application during 3 months. | Other | Balanced-Immunity with caloric restriction, Balanced-Immunity without caloric restriction |
Primary outcome
Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention
Time frame: Baseline and 3-months (after the nutritional intervention)
The first endpoint will be evaluated by calculating the change (Δ) in the percentage of PD-1⁺ CD4⁺ T cells between baseline and month 3 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry to quantify the percentage of PD-1⁺ CD4⁺ T cells.
49 secondary outcomes
Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention and 3 month of follow-up
Time frame: Baseline and 6 months (after 3 months of nutritional intervention and 3 months of follow-up)
Comparison of immune cell phenotyping at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of immune checkpoint proteins at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of concentration of immunoglobulines G (IgG) in serum at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of cytokines and hsCRP at baseline, month 3 and month 6 in serum between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of the ratio immunoglobulines A fecal/ immunoglobulines G fecal at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of low-grade inflammation and immune-profile at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of proteomics signatures linked to immune and organ-specific proteins at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of glyco-immune checkpoint profile at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of antigen stimulation and serology at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of gut microbiota composition, diversity and functional capacity at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of gut barrier integrity at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of gut permeability (fecal zonulin) at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of short-chain fatty acids (SCFAs) profil at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of metabolomics profil at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Comparison of fecal pH at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Blood pressure at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Resting heart rate at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Body mass index at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Waist circumferences, hip circumferences and waist/hip ratio at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Body composition at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Energy metabolism at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Glycemia fasting at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Insulin fasting at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Insulin resistance at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Lipid profile fasting at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Fatty acid profile at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Liver health at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Appetite-regulating hormones at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Glucose kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Insulin kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Triglycerides kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Dietary intake of food groups at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Daily mean of calorie, macronutriment and micronutriments intakes at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Indexes of diet quality at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of eating behaviour at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of eating behaviour at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of gastrointestinal tolerance at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of gastrointestinal symptom at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Modification of quality of life at baseline, month 3 and month 6 between the nutritional interventions
Time frame: Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Offical website of the NUTRIMMUNE project, providing information about the project objectives, research activities, consortium and participating institutionsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Decision will be taken depending on local regulation at the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed test meal, Biological sampling and Questionnaires in people with Obesity (BMI>30) and Immune Abnormalities, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine CLEMENT (+33 142177928, karine.clement@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention (time frame: Baseline and 3-months (after the nutritional intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.