Chronic DiseaseNCT05807243
Description of Immunosenescence Biomarkers and Nutritional Intervention to Evaluate the Implementation of Digital Tools
A study testing Dietary intervention for healthy weight loss in people with Chronic Disease, run by IMDEA Food at 1 site in Spain.
Trial summary
Descriptive comparative study of immunosenescence markers and their association with nutritional, metabolic, metabolomic and genetic characteristics in young (control), senior (age-associated immunosenescence), and populations susceptible to premature immunosenescence such as obese patients, cancer patients and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Dietary intervention for healthy weight loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2022to 18 Nov 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men/women
- Minimum 18 years old
- Adequate cultural level and understanding of the clinical study.
- Agree to participate voluntarily in the study and give written informed consent.
- Population-specific inclusion criteria:
- Overweight/obese population:
Show all 18Show fewer
- BMI 25-35 Kg/m2
- Ability to handle electronic devices for data capture.
- Healthy young population:
- Between 18 and 25 years old (both inclusive).
- Senior population
- Over 55 years of age.
- Oncology patients
- Over 18 years of age.
- With a clinical diagnosis of an active tumour process.
- Patients who developed severe or persistent COVID-19:
- Severe COVID-19: Patients who have suffered from COVID-19 disease and whose symptomatology is considered within the clinical pictures of severity of this disease, which may include: severe pneumonia, acute respiratory distress syndrome (ARDS), presence of respiratory failure (SaO2 <90% room air) or respiratory rate ≥ 30 breaths per minute, sepsis, septic shock, thromboembolism and multi-organ dysfunction (including acute cardiac and renal injuries).
- COVID-19 persistence: Patients who have had COVID-19 disease and who remain with active symptomatology after what is considered the acute phase of the disease, after 4 or even 12 weeks, with symptoms persisting over time.
Who cannot join
- Dementia, mental illness or diminished cognitive function that can hinder the subject's participation on the study.
- Severe diseases (liver disease, kidney disease, etc.)
- BMI > 35 Kg/m2
- Pregnancy or breastfeeding.
- Population-specific exclusion criteria:
- Overweight/obese population:
Show all 12Show fewer
- BMI <25 Kg/m2 or > 35 Kg/m2
- Pharmacological treatment for weight loss.
- Refusal to be monitored for one month by means of sensors and nutritional visits.
- Refusal to follow healthy eating guidelines for weight loss.
- Healthy young population:
- Chronic or acute pathologies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study of Molecular Markers of Immunosenescence With Nutritional Intervention to Evaluate the Implementation of Digital Tools in the Capture of Nutritional Data
Descriptive comparative study of immunosenescence markers and their association with nutritional, metabolic, metabolomic and genetic characteristics in young (control), senior (age-associated immunosenescence), and populations susceptible to premature immunosenescence such as obese patients, cancer patients and patients who developed severe forms of COVID19 or persistent COVID19.
In one of these populations of premature immunosenescence, the population group with overweight or obesity, a prospective and cross-sectional nutritional intervention study is proposed, with data capture and monitoring using digital tools, to evaluate the evolution of immunosenescence markers and assess more objectively and effectively the nutritional status and help in making personalised decisions thanks to the application of these tools. This nutritional intervention will be focused on controlled and safe weight loss that will allow the capture of a large number of variables on lifestyle and dietary habits, nutritional assessment, biochemical, metabolic, genetic, metagenomic, lipidomic and metabolomic markers measured statically and also continuously.
Read the detailed description
The study consists of data capturing to evaluate the differential pattern of molecular markers of immunosenescence in different population groups, and applying a hypocaloric diet in the obesity subgroup together with recommendations for improving lifestyle habits. The data capture of this group during the intervention will be carried out with different sensors and questionnaires for a month. To do this, they will have to follow the explanations of the researchers.
The data capture during the nutritional intervention (only for the overweight and obese population group) will be done as follows:
Group 1 (Traditional → Digital): will start with traditional data-collection methods, i.e. filling in nutritional and lifestyle questionnaires (Visit 1 to Visit 2). After two weeks, they will start capturing data digitally through the application of sensors (Visit 2 to Visit 3).
Group 2 (Digital → Traditional): will start with digital data-collection methods, using sensors and taking pictures of what they eat with a smartphone (Visit 1 to Visit 2). After two weeks, they will start capturing data traditionally, by filling in nutritional and lifestyle questionnaires (Visit 2 to Visit 3).
The nutritional intervention participant group will follow the tailored nutritional weight loss diet and lifestyle guidelines, which will be provided to them at the start of the study by the researchers. In addition, they should follow instructions for proper continuous data collection using sensors. This will avoid biases in the data collection process.
- Conditions
- Chronic Disease
- Being tested
- Dietary intervention for healthy weight loss
- Keywords
- Artificial Intelligence, Multi-modal learning, Nutrition, Biomarkers, Precision Nutrition, Immunosenescence
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention for healthy weight lossOther
Balanced and varied dietary plan adjusted to each participant's needs, with an approximate reduction of 500 Kcal from their total metabolic expenditure. The diet will be followed by the subjects during the 4 weeks of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Traditional → Digital) | Experimental | Participants in both groups will be monitored for a month while following an hypocaloric diet for healthy weight-loss.
The first group (n=50) will start collecting data via questionnaires (traditional method) for the first two weeks, and switch to the digital data-collection method for the last two weeks. Receives: Other: Dietary intervention for healthy weight loss |
| Group 2 (Digital → Traditional) | Experimental | Participants in both groups will be monitored for a month while following an hypocaloric diet for healthy weight-loss.
The second group (n=50) will start with the digital data-collection method for the first two weeks and switch to the data collection via questionnaires (traditional method) for the last two weeks.
n=100) Receives: Other: Dietary intervention for healthy weight loss |
| Group 3 - Young healthy population | No intervention | n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
| Group 4 - Senior population | No intervention | n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
| Group 5 - Oncological population | No intervention | (n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
| Group 6 - COVID-19 population | No intervention | (n=100) patients who developed severe forms of COVID-19 or persistent COVID-19. Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Only in the obese/overweight population.
Change in body mass index (Kg/m2)
Measured: 1 month
Blood Glucose
Change in blood glucose (mg/dl). Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Concentration of interstitial glucose
Only in the obese/overweight population.
Change in Interstitial Glucose (mgl/dl) measured continuously with the Freestyle glucometer (Abbott Laboratories)
Measured: 15 days
Blood lymphocytes
Variation in the percentage of blood lymphocytes analysed by flow cytometry in five different population groups (young healthy population, elderly, overweight-obese, cancer patients, and patients who developed severe forms of COVID-19 or persistent COVID-19).
Other variables (described in the Secondary Outcomes), such as biochemical parameters, genetical data, microbiota, etc., will also be analyzed in order to identify specific molecular markers of immunosenescence.
Measured: 12 months
Secondary outcomes (30)
Weight
Weight change (Kg)
Measured: 1 month
WC
Change in waist circumference (cm)
Measured: 1 month
Body composition
Change in % of fat mass
Measured: 1 month
Blood pressure
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured in the study visits with an automatic Digital Blood Pressure Monitor Model M3 (OMRON HEALTHCARE UK, Kyoto, Japan).
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.
Measured: 1 month
Heart Rate
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured in the study visits with an automatic Digital Blood Pressure Monitor Model M3 (OMRON HEALTHCARE UK, Kyoto, Japan).
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.
Measured: 1 month
Dietary intake
Traditional data-collection method: Two 3-day dietary records (for two working days and a holiday); Digital data-collection method: Pictures of food taken with a smartphone.
Measured: 1 month
Physical activity
One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method:
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated International Physical Activity Questionnaire (USA Spanish version translated 3/2003 - Short last 7 DAYS self-administered version of the IPAQ - Revised August 2002).
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.
Measured: 1 month
Sleep
One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method:
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated Oviedo Sleep Questionnaire. In the Oviedo Sleep Questionnaire, the higher the score, the greater insomnia's severity.
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.
Measured: 1 month
Mental health state
One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method:
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated Depression Anxiety and Stress Scale - 21 (DASS-21). In the Depression Anxiety and Stress Scale, the higher the score, the greater the stress, anxiety and depression levels.
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.
Measured: 1 month
Cognition
Measured via the validated Mini-mental state examination (MMSE). In the Mini-mental state examination, the higher the score, the better the cognitive status.
Measured: 1 month
Health status and quality of life
Measured via the validated Short Form-36 Health Survey (SF-36). In the Short Form-36 Health Survey, the higher the score, the better the quality of life and health status.
Measured: 1 month
Percentage of glycated haemoglobin
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be only measured in the study visits with the blood tests.
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured continuously with the Freestyle glucometer (Abbott Laboratories), and in the study visits with the blood tests.
Measured: 1 month
Total cholesterol
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Low density lipoprotein (LDL)
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
High density lipoprotein (HDL)
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Triglycerides
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Apo A1
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Apo B
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Insulin
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Glycated hemoglobin (HbA1c)
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Homeostatic model assessment (HOMA)
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Albumin
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Prealbumin
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
C-reactive protein (CRP)
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Leptin
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Adinopectin
Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Measured: 1 month
Faecal microbiota
Faecal microbiota taxonomic profiling through shotgun sequencing.
Measured: 1 month
Gut dysbiosis
Lipopolysaccharide-binding protein (LBP) levels as an indirect measure of intestinal dysbiosis.
Measured: 1 month
Genotype
Genotyping of single nucleotide genetic variants (SNPs) and specific mutations associated with metabolism, nutrition and immunodegenerative processes.
Measured: 1 month
Gene expression
Expression panels in genes related to the regulation of metabolism, inflammation, immunity, oxidation, nutrition and immunodegenerative processes.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start9 May 2022
- Primary completion23 Jun 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Ramírez de Molina, PhD, Principal investigator, Fundación IMDEA AlimentaciónEnrique Carrillo de Santa Pau, PhD, Principal investigator, Fundación IMDEA AlimentaciónMaría Isabel Espinosa Salinas, PhD, Principal investigator, Fundación IMDEA AlimentaciónCristina María Fernández Díaz, PhD, Principal investigator, Fundación IMDEA Alimentación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807243
- Sponsor's protocol ID
- IMD: PI-052
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020.
PubMed 25815989GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.
PubMed 30954305Moore JB. From personalised nutrition to precision medicine: the rise of consumer genomics and digital health. Proc Nutr Soc. 2020 Aug;79(3):300-310. doi: 10.1017/S0029665120006977. Epub 2020 May 29.
PubMed 32468984Lacruz-Pleguezuelos B, Bazan GX, Romero-Tapiador S, Freixer G, Tolosana R, Daza R, Fernandez-Diaz CM, Molina S, Crespo MC, Laguna T, Marcos-Zambrano LJ, Aguilar-Aguilar E, Fernandez-Cabezas J, Cruz-Gil S, Fernandez LP, Vera-Rodriguez R, Fierrez J, Ramirez de Molina A, Ortega-Garcia J, Morales A, Carrillo de Santa Pau E, Espinosa-Salinas I. AI4Food, a feasibility study for the implementation of automated devices in the nutritional advice and follow up within a weight loss intervention. Clin Nutr. 2025 May;48:80-89. doi: 10.1016/j.clnu.2025.03.003. Epub 2025 Mar 11.
PubMed 40168934
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Molecular Markers of Immunosenescence With Nutritional Intervention to Evaluate the Implementation of Digital Tools in the Capture of Nutritional Data
- ClinicalTrials.gov ID
- NCT05807243
- Acronym / sponsor ID
- IMD: PI-052
- Conditions
- Chronic Disease
- Keywords
- Artificial Intelligence, Multi-modal learning, Nutrition, Biomarkers, Precision Nutrition, Immunosenescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 11 Apr 2023 (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.
Descriptive comparative study of immunosenescence markers and their association with nutritional, metabolic, metabolomic and genetic characteristics in young (control), senior (age-associated immunosenescence), and populations susceptible to premature immunosenescence such as obese patients, cancer patients and patients who developed severe forms of COVID19 or persistent COVID19.
In one of these populations of premature immunosenescence, the population group with overweight or obesity, a prospective and cross-sectional nutritional intervention study is proposed, with data capture and monitoring using digital tools, to evaluate the evolution of immunosenescence markers and assess more objectively and effectively the nutritional status and help in making personalised decisions thanks to the application of these tools. This nutritional intervention will be focused on controlled and safe weight loss that will allow the capture of a large number of variables on lifestyle and dietary habits, nutritional assessment, biochemical, metabolic, genetic, metagenomic, lipidomic and metabolomic markers measured statically and also continuously.
Detailed description
The study consists of data capturing to evaluate the differential pattern of molecular markers of immunosenescence in different population groups, and applying a hypocaloric diet in the obesity subgroup together with recommendations for improving lifestyle habits. The data capture of this group during the intervention will be carried out with different sensors and questionnaires for a month. To do this, they will have to follow the explanations of the researchers.
The data capture during the nutritional intervention (only for the overweight and obese population group) will be done as follows:
Group 1 (Traditional → Digital): will start with traditional data-collection methods, i.e. filling in nutritional and lifestyle questionnaires (Visit 1 to Visit 2). After two weeks, they will start capturing data digitally through the application of sensors (Visit 2 to Visit 3).
Group 2 (Digital → Traditional): will start with digital data-collection methods, using sensors and taking pictures of what they eat with a smartphone (Visit 1 to Visit 2). After two weeks, they will start capturing data traditionally, by filling in nutritional and lifestyle questionnaires (Visit 2 to Visit 3).
The nutritional intervention participant group will follow the tailored nutritional weight loss diet and lifestyle guidelines, which will be provided to them at the start of the study by the researchers. In addition, they should follow instructions for proper continuous data collection using sensors. This will avoid biases in the data collection process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Traditional → Digital) | Experimental | Other: Dietary intervention for healthy weight lossParticipants in both groups will be monitored for a month while following an hypocaloric diet for healthy weight-loss. The first group (n=50) will start collecting data via questionnaires (traditional method) for the first two weeks, and switch to the digital data-collection method for the last two weeks. |
| Group 2 (Digital → Traditional) | Experimental | Other: Dietary intervention for healthy weight lossParticipants in both groups will be monitored for a month while following an hypocaloric diet for healthy weight-loss. The second group (n=50) will start with the digital data-collection method for the first two weeks and switch to the data collection via questionnaires (traditional method) for the last two weeks. n=100) |
| Group 3 - Young healthy population | No intervention | –n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
| Group 4 - Senior population | No intervention | –n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
| Group 5 - Oncological population | No intervention | –(n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
| Group 6 - COVID-19 population | No intervention | –(n=100) patients who developed severe forms of COVID-19 or persistent COVID-19. Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men/women
- Minimum 18 years old
- Adequate cultural level and understanding of the clinical study.
- Agree to participate voluntarily in the study and give written informed consent.
- Overweight/obese population:
Key exclusion criteria (12 listed)
- Dementia, mental illness or diminished cognitive function that can hinder the subject's participation on the study.
- Severe diseases (liver disease, kidney disease, etc.)
- BMI > 35 Kg/m2
- Pregnancy or breastfeeding.
- Overweight/obese population:
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 |
|---|---|---|
| Dietary intervention for healthy weight lossBalanced and varied dietary plan adjusted to each participant's needs, with an approximate reduction of 500 Kcal from their total metabolic expenditure. The diet will be followed by the subjects during the 4 weeks of the study. | Other | Group 1 (Traditional → Digital), Group 2 (Digital → Traditional) |
Primary outcome
BMI
Time frame: 1 month
Only in the obese/overweight population. Change in body mass index (Kg/m2)
Blood Glucose
Time frame: 1 month
Change in blood glucose (mg/dl). Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
Concentration of interstitial glucose
Time frame: 15 days
Only in the obese/overweight population. Change in Interstitial Glucose (mgl/dl) measured continuously with the Freestyle glucometer (Abbott Laboratories)
Blood lymphocytes
Time frame: 12 months
Variation in the percentage of blood lymphocytes analysed by flow cytometry in five different population groups (young healthy population, elderly, overweight-obese, cancer patients, and patients who developed severe forms of COVID-19 or persistent COVID-19). Other variables (described in the Secondary Outcomes), such as biochemical parameters, genetical data, microbiota, etc., will also be analyzed in order to identify specific molecular markers of immunosenescence.
30 secondary outcomes
Weight
Time frame: 1 month
WC
Time frame: 1 month
Body composition
Time frame: 1 month
Blood pressure
Time frame: 1 month
Heart Rate
Time frame: 1 month
Dietary intake
Time frame: 1 month
Physical activity
Time frame: 1 month
Sleep
Time frame: 1 month
Mental health state
Time frame: 1 month
Cognition
Time frame: 1 month
Health status and quality of life
Time frame: 1 month
Percentage of glycated haemoglobin
Time frame: 1 month
Total cholesterol
Time frame: 1 month
Low density lipoprotein (LDL)
Time frame: 1 month
High density lipoprotein (HDL)
Time frame: 1 month
Triglycerides
Time frame: 1 month
Apo A1
Time frame: 1 month
Apo B
Time frame: 1 month
Insulin
Time frame: 1 month
Glycated hemoglobin (HbA1c)
Time frame: 1 month
Homeostatic model assessment (HOMA)
Time frame: 1 month
Albumin
Time frame: 1 month
Prealbumin
Time frame: 1 month
C-reactive protein (CRP)
Time frame: 1 month
Leptin
Time frame: 1 month
Adinopectin
Time frame: 1 month
Faecal microbiota
Time frame: 1 month
Gut dysbiosis
Time frame: 1 month
Genotype
Time frame: 1 month
Gene expression
Time frame: 1 month
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 11 Apr 2023.
- Background: PubMed 25815989Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020.
- Background: PubMed 30954305GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.
- Background: PubMed 32468984Moore JB. From personalised nutrition to precision medicine: the rise of consumer genomics and digital health. Proc Nutr Soc. 2020 Aug;79(3):300-310. doi: 10.1017/S0029665120006977. Epub 2020 May 29.
- Derived from this study: PubMed 40168934Lacruz-Pleguezuelos B, Bazan GX, Romero-Tapiador S, Freixer G, Tolosana R, Daza R, Fernandez-Diaz CM, Molina S, Crespo MC, Laguna T, Marcos-Zambrano LJ, Aguilar-Aguilar E, Fernandez-Cabezas J, Cruz-Gil S, Fernandez LP, Vera-Rodriguez R, Fierrez J, Ramirez de Molina A, Ortega-Garcia J, Morales A, Carrillo de Santa Pau E, Espinosa-Salinas I. AI4Food, a feasibility study for the implementation of automated devices in the nutritional advice and follow up within a weight loss intervention. Clin Nutr. 2025 May;48:80-89. doi: 10.1016/j.clnu.2025.03.003. Epub 2025 Mar 11.
- Research team profileLink provided by the sponsor.
- Research team profileLink provided by the sponsor.
- Research team profileLink provided by the sponsor.
- 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.
Ana Ramírez de Molina, PhD principal investigator
Fundación IMDEA Alimentación
Enrique Carrillo de Santa Pau, PhD principal investigator
Fundación IMDEA Alimentación
María Isabel Espinosa Salinas, PhD principal investigator
Fundación IMDEA Alimentación
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention for healthy weight loss in people with Chronic Disease, run by IMDEA Food 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 18 inclusion and 12 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 11 Apr 2023. 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?
BMI (time frame: 1 month). The study lists 4 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 NCT05807243, which also lists 4 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 11 Apr 2023.