Obesity Adult OnsetNCT06279780
Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity
A study testing very low-calorie diet in people with Obesity Adult Onset, run by Celia Bañuls at 1 site in Spain.
Trial summary
It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity Adult Onset
- What is being tested?
- very low-calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with BMI≥30kg/m2, with at least 5 years of diagnosed obesity evolution.
- Patients have had stable body weight (±2 kg) during the 3 months prior to the study.
Who cannot join
- All patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, Cushing's syndrome), and established liver and kidney failure (according to transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula >60) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Very Low-calorie Diet on Microbiota, Oxidative Stress, Inflammatory and Metabolomic Profile in Metabolically Healthy and Unhealthy Obese Subjects
It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function [total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry], markers of mitochondrial dynamics [Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot], markers of inflammation [Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers.
- Conditions
- Obesity Adult Onset
- Being tested
- very low-calorie diet
- Keywords
- metabolic syndrome, Very low-calorie diet, Microbiota, oxidative stress, Inflammation
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very low-calorie dietDietary supplement
Also called VLCD
Subjects undergo two cycles of a very-low-calorie diet (VLCD) for 6 weeks each, alternating with a hypocaloric diet (12 weeks). The dietetic intervention consists of a VLCD using a liquid formula (Optisource Plus, Nestlé S.A., Vevey, Switzerland), providing 52.8 g protein, 75.0 g carbohydrates, 13.5 g fat, 11.4 g fiber, and essential vitamins and minerals based on Recommended Dietary Allowances (RDA). This formula supplies 2738 kJ/day (654 kcal/day), replacing the participants' three daily meals. Following this and before the second VLCD cycle, a dietician performs an individualized nutritional assessment to calculate the resting energy expenditure, and personalized hypocaloric diets were prepared, reducing 500 kcal for each individual on their daily caloric expenditure, maintaining the recommended intake of each of the macronutrients (55% carbohydrates, 30% fats and 15% proteins) for 12-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Very low-calorie diet Intervention | Experimental | Not described Receives: Dietary Supplement: very low-calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention.
To assess the alpha-diversity of the intestinal microbiota, defined as the average diversity of species in an ecosystem, the Shannon index will be used. The results are interpreted as follows: values less than 2 are considered low in diversity and values greater than 3 are high in species diversity.
Measured: 5 years
Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present metabolically healthy obesity (MHO) or metabolically unhealthy obesity (MUHO).
To asses the differences in alpha-diversity of the intestinal microbiota in both groups, it will be evaluated whether there are significant differences between the Shannon indices of the two groups. The classification of patients between MHO and MUHO will be carried out using the following criteria: MUHO will be considered when patients with obesity present ≥2 metabolic abnormalities, and MHO with ≤1 metabolic abnormalities; the following cardiovascular risk factors are considered metabolic abnormalities: elevated blood pressure (defined as either SBP ≥130 mm Hg, DBP ≥85 mm Hg, or treatment with antihypertensive medications), elevated triglycerides (as fasting triglyceride concentration ≥1.7 mmol/l), low HDL-C levels (defined as HDL-C <1.04 mmol/l, in men, <1.29 mmol/l/l in women, or treatment with lipid-lowering medications), dysglycemia (fasting plasma glucose 5.6 to 6.9 mmol/l, and/or and insulin resistance as HOMA-IR >3.8).
Measured: 5 years
Secondary outcomes (15)
Evaluate significant changes in body fat mass percentage after the dietetic intervention.
Percentage of body fat mass will be measured by bioelectrical impedance. It is considered to be high when ≥25% in men and ≥30% in women. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietetic intervention.
Participants will be considered to have achieved an improvement in high-sensitivity C-reactive protein levels if they normalize its value (normality values defined between 0 and 1.69mg/dl).
Measured: 2 years
Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention.
Participants will be considered to have achieved an improvement in C3 protein if they normalize its value (normality values defined between 81 and 157mg/dl).
Measured: 2 years
Assess significant changes in plasmatic homocysteine as an inflammatory parameter after the dietetic intervention.
Participants will be considered to have achieved an improvement in plasmatic homocysteine if they normalize its value (normality values defined between 5 and 15µmol/L).
Measured: 2 years
Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention.
IL-1B levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention.
IL-6 levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention.
TNF-alpha levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention.
Superoxide dismutase levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Analyze the significant differences between metabolomic profile before and after the dietetic intervention.
NMR spectra will be used to obtain spectra from serum samples from the cohort. In order to evaluate if there will be significant differences after the dietetic intervention, a PLS-DA model for discrimination between basal and post intervention levels will be performed. Scores plots will be calculated with a 95% confidence interval.
Measured: 2 years
Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels.
Total ROS levels will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Assess if there is a significant reduction after the dietetic intervention in glutathione levels.
Total glutathione levels will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels.
Total free radicals and superoxide content will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production.
Mitochondrial ROS production will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential.
Mitochondrial membrane potential will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 2 years
Analyze the proportion of subjects achieving at least 10% reduction in weight compared with baseline.
Proportion of subjects achieving at least 10% reduction in weight after the dietetic intervention (6 months).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Obesity Adult OnsetStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celia Bañuls
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Celia Bañuls, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279780
- Sponsor's protocol ID
- PI18/00932
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith KB, Smith MS. Obesity Statistics. Prim Care. 2016 Mar;43(1):121-35, ix. doi: 10.1016/j.pop.2015.10.001. Epub 2016 Jan 12.
PubMed 26896205Lagerros YT, Rossner S. Obesity management: what brings success? Ther Adv Gastroenterol. 2013 Jan;6(1):77-88. doi: 10.1177/1756283X12459413.
PubMed 23320052Gomez-Ambrosi J, Silva C, Galofre JC, Escalada J, Santos S, Millan D, Vila N, Ibanez P, Gil MJ, Valenti V, Rotellar F, Ramirez B, Salvador J, Fruhbeck G. Body mass index classification misses subjects with increased cardiometabolic risk factors related to elevated adiposity. Int J Obes (Lond). 2012 Feb;36(2):286-94. doi: 10.1038/ijo.2011.100. Epub 2011 May 17.
PubMed 21587201Tchernof A, Despres JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011.
PubMed 23303913Stefan N, Haring HU, Hu FB, Schulze MB. Metabolically healthy obesity: epidemiology, mechanisms, and clinical implications. Lancet Diabetes Endocrinol. 2013 Oct;1(2):152-62. doi: 10.1016/S2213-8587(13)70062-7. Epub 2013 Aug 30.
PubMed 24622321Phillips CM. Metabolically healthy obesity across the life course: epidemiology, determinants, and implications. Ann N Y Acad Sci. 2017 Mar;1391(1):85-100. doi: 10.1111/nyas.13230. Epub 2016 Oct 10.
PubMed 27723940Primeau V, Coderre L, Karelis AD, Brochu M, Lavoie ME, Messier V, Sladek R, Rabasa-Lhoret R. Characterizing the profile of obese patients who are metabolically healthy. Int J Obes (Lond). 2011 Jul;35(7):971-81. doi: 10.1038/ijo.2010.216. Epub 2010 Oct 26.
PubMed 20975726Naukkarinen J, Heinonen S, Hakkarainen A, Lundbom J, Vuolteenaho K, Saarinen L, Hautaniemi S, Rodriguez A, Fruhbeck G, Pajunen P, Hyotylainen T, Oresic M, Moilanen E, Suomalainen A, Lundbom N, Kaprio J, Rissanen A, Pietilainen KH. Characterising metabolically healthy obesity in weight-discordant monozygotic twins. Diabetologia. 2014 Jan;57(1):167-76. doi: 10.1007/s00125-013-3066-y. Epub 2013 Oct 8.
PubMed 24100782Plourde G, Karelis AD. Current issues in the identification and treatment of metabolically healthy but obese individuals. Nutr Metab Cardiovasc Dis. 2014 May;24(5):455-9. doi: 10.1016/j.numecd.2013.12.002. Epub 2014 Jan 12.
PubMed 24529490Velho S, Paccaud F, Waeber G, Vollenweider P, Marques-Vidal P. Metabolically healthy obesity: different prevalences using different criteria. Eur J Clin Nutr. 2010 Oct;64(10):1043-51. doi: 10.1038/ejcn.2010.114. Epub 2010 Jul 14.
PubMed 20628408Fruhbeck G, Gomez-Ambrosi J. Rationale for the existence of additional adipostatic hormones. FASEB J. 2001 Sep;15(11):1996-2006. doi: 10.1096/fj.00-0829hyp.
PubMed 11532980Mangge H, Zelzer S, Puerstner P, Schnedl WJ, Reeves G, Postolache TT, Weghuber D. Uric acid best predicts metabolically unhealthy obesity with increased cardiovascular risk in youth and adults. Obesity (Silver Spring). 2013 Jan;21(1):E71-7. doi: 10.1002/oby.20061. Epub 2013 Jan 29.
PubMed 23401248Messier V, Karelis AD, Robillard ME, Bellefeuille P, Brochu M, Lavoie JM, Rabasa-Lhoret R. Metabolically healthy but obese individuals: relationship with hepatic enzymes. Metabolism. 2010 Jan;59(1):20-4. doi: 10.1016/j.metabol.2009.06.020. Epub 2009 Aug 25.
PubMed 19709695Gaye A, Doumatey AP, Davis SK, Rotimi CN, Gibbons GH. Whole-genome transcriptomic insights into protective molecular mechanisms in metabolically healthy obese African Americans. NPJ Genom Med. 2018 Jan 29;3:4. doi: 10.1038/s41525-018-0043-x. eCollection 2018.
PubMed 29387454Hotamisligil GS. Inflammation and metabolic disorders. Nature. 2006 Dec 14;444(7121):860-7. doi: 10.1038/nature05485.
PubMed 17167474
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Very Low-calorie Diet on Microbiota, Oxidative Stress, Inflammatory and Metabolomic Profile in Metabolically Healthy and Unhealthy Obese Subjects
- ClinicalTrials.gov ID
- NCT06279780
- Acronym / sponsor ID
- PI18/00932
- Conditions
- Obesity Adult Onset
- Keywords
- metabolic syndrome, Very low-calorie diet, Microbiota, oxidative stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Celia BañulsUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 28 Feb 2024 (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.
It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function [total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry], markers of mitochondrial dynamics [Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot], markers of inflammation [Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very low-calorie diet Intervention | Experimental | Dietary Supplement: very low-calorie diet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with BMI≥30kg/m2, with at least 5 years of diagnosed obesity evolution.
- Patients have had stable body weight (±2 kg) during the 3 months prior to the study.
Key exclusion criteria (1 listed)
- All patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, Cushing's syndrome), and established liver and kidney failure (according to transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula >60) will be excluded.
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 |
|---|---|---|
| very low-calorie dietAlso: VLCDSubjects undergo two cycles of a very-low-calorie diet (VLCD) for 6 weeks each, alternating with a hypocaloric diet (12 weeks). The dietetic intervention consists of a VLCD using a liquid formula (Optisource Plus, Nestlé S.A., Vevey, Switzerland), providing 52.8 g protein, 75.0 g carbohydrates, 13.5 g fat, 11.4 g fiber, and essential vitamins and minerals based on Recommended Dietary Allowances (RDA). This formula supplies 2738 kJ/day (654 kcal/day), replacing the participants' three daily meals. Following this and before the second VLCD cycle, a dietician performs an individualized nutritional assessment to calculate the resting energy expenditure, and personalized hypocaloric diets were prepared, reducing 500 kcal for each individual on their daily caloric expenditure, maintaining the recommended intake of each of the macronutrients (55% carbohydrates, 30% fats and 15% proteins) for 12-weeks. | Dietary supplement | Very low-calorie diet Intervention |
Primary outcome
Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention.
Time frame: 5 years
To assess the alpha-diversity of the intestinal microbiota, defined as the average diversity of species in an ecosystem, the Shannon index will be used. The results are interpreted as follows: values less than 2 are considered low in diversity and values greater than 3 are high in species diversity.
Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present metabolically healthy obesity (MHO) or metabolically unhealthy obesity (MUHO).
Time frame: 5 years
To asses the differences in alpha-diversity of the intestinal microbiota in both groups, it will be evaluated whether there are significant differences between the Shannon indices of the two groups. The classification of patients between MHO and MUHO will be carried out using the following criteria: MUHO will be considered when patients with obesity present ≥2 metabolic abnormalities, and MHO with ≤1 metabolic abnormalities; the following cardiovascular risk factors are considered metabolic abnormalities: elevated blood pressure (defined as either SBP ≥130 mm Hg, DBP ≥85 mm Hg, or treatment with antihypertensive medications), elevated triglycerides (as fasting triglyceride concentration ≥1.7 mmol/l), low HDL-C levels (defined as HDL-C <1.04 mmol/l, in men, <1.29 mmol/l/l in women, or treatment with lipid-lowering medications), dysglycemia (fasting plasma glucose 5.6 to 6.9 mmol/l, and/or and insulin resistance as HOMA-IR >3.8).
15 secondary outcomes
Evaluate significant changes in body fat mass percentage after the dietetic intervention.
Time frame: 2 years
Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietetic intervention.
Time frame: 2 years
Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention.
Time frame: 2 years
Assess significant changes in plasmatic homocysteine as an inflammatory parameter after the dietetic intervention.
Time frame: 2 years
Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention.
Time frame: 2 years
Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention.
Time frame: 2 years
Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention.
Time frame: 2 years
Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention.
Time frame: 2 years
Analyze the significant differences between metabolomic profile before and after the dietetic intervention.
Time frame: 2 years
Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels.
Time frame: 2 years
Assess if there is a significant reduction after the dietetic intervention in glutathione levels.
Time frame: 2 years
Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels.
Time frame: 2 years
Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production.
Time frame: 2 years
Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential.
Time frame: 2 years
Analyze the proportion of subjects achieving at least 10% reduction in weight compared with baseline.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 26896205Smith KB, Smith MS. Obesity Statistics. Prim Care. 2016 Mar;43(1):121-35, ix. doi: 10.1016/j.pop.2015.10.001. Epub 2016 Jan 12.
- Background: PubMed 23320052Lagerros YT, Rossner S. Obesity management: what brings success? Ther Adv Gastroenterol. 2013 Jan;6(1):77-88. doi: 10.1177/1756283X12459413.
- Background: PubMed 21587201Gomez-Ambrosi J, Silva C, Galofre JC, Escalada J, Santos S, Millan D, Vila N, Ibanez P, Gil MJ, Valenti V, Rotellar F, Ramirez B, Salvador J, Fruhbeck G. Body mass index classification misses subjects with increased cardiometabolic risk factors related to elevated adiposity. Int J Obes (Lond). 2012 Feb;36(2):286-94. doi: 10.1038/ijo.2011.100. Epub 2011 May 17.
- Background: PubMed 23303913Tchernof A, Despres JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011.
- Background: PubMed 24622321Stefan N, Haring HU, Hu FB, Schulze MB. Metabolically healthy obesity: epidemiology, mechanisms, and clinical implications. Lancet Diabetes Endocrinol. 2013 Oct;1(2):152-62. doi: 10.1016/S2213-8587(13)70062-7. Epub 2013 Aug 30.
- Background: PubMed 27723940Phillips CM. Metabolically healthy obesity across the life course: epidemiology, determinants, and implications. Ann N Y Acad Sci. 2017 Mar;1391(1):85-100. doi: 10.1111/nyas.13230. Epub 2016 Oct 10.
- Background: PubMed 20975726Primeau V, Coderre L, Karelis AD, Brochu M, Lavoie ME, Messier V, Sladek R, Rabasa-Lhoret R. Characterizing the profile of obese patients who are metabolically healthy. Int J Obes (Lond). 2011 Jul;35(7):971-81. doi: 10.1038/ijo.2010.216. Epub 2010 Oct 26.
- Background: PubMed 24100782Naukkarinen J, Heinonen S, Hakkarainen A, Lundbom J, Vuolteenaho K, Saarinen L, Hautaniemi S, Rodriguez A, Fruhbeck G, Pajunen P, Hyotylainen T, Oresic M, Moilanen E, Suomalainen A, Lundbom N, Kaprio J, Rissanen A, Pietilainen KH. Characterising metabolically healthy obesity in weight-discordant monozygotic twins. Diabetologia. 2014 Jan;57(1):167-76. doi: 10.1007/s00125-013-3066-y. Epub 2013 Oct 8.
- Background: PubMed 24529490Plourde G, Karelis AD. Current issues in the identification and treatment of metabolically healthy but obese individuals. Nutr Metab Cardiovasc Dis. 2014 May;24(5):455-9. doi: 10.1016/j.numecd.2013.12.002. Epub 2014 Jan 12.
- Background: PubMed 20628408Velho S, Paccaud F, Waeber G, Vollenweider P, Marques-Vidal P. Metabolically healthy obesity: different prevalences using different criteria. Eur J Clin Nutr. 2010 Oct;64(10):1043-51. doi: 10.1038/ejcn.2010.114. Epub 2010 Jul 14.
- Background: PubMed 11532980Fruhbeck G, Gomez-Ambrosi J. Rationale for the existence of additional adipostatic hormones. FASEB J. 2001 Sep;15(11):1996-2006. doi: 10.1096/fj.00-0829hyp.
- Background: PubMed 23401248Mangge H, Zelzer S, Puerstner P, Schnedl WJ, Reeves G, Postolache TT, Weghuber D. Uric acid best predicts metabolically unhealthy obesity with increased cardiovascular risk in youth and adults. Obesity (Silver Spring). 2013 Jan;21(1):E71-7. doi: 10.1002/oby.20061. Epub 2013 Jan 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing very low-calorie diet in people with Obesity Adult Onset, run by Celia Bañuls at 1 site in Spain.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06279780, which also lists 34 linked publications.
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 27 Feb 2025.