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Description of Immunosenescence Biomarkers and Nutritional Intervention to Evaluate the Implementation of Digital Tools

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dietary intervention for healthy weight loss
Sponsored by
IMDEA Food
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease focused on measuring Artificial Intelligence, Multi-modal learning, Nutrition, Biomarkers, Precision Nutrition, Immunosenescence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (commun for all groups): 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: 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. Exclusion Criteria: 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: 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.

Sites / Locations

  • IMDEA Food

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

No Intervention

No Intervention

No Intervention

No Intervention

Arm Label

Group 1 (Traditional → Digital)

Group 2 (Digital → Traditional)

Group 3 - Young healthy population

Group 4 - Senior population

Group 5 - Oncological population

Group 6 - COVID-19 population

Arm Description

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.

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)

n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.

n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.

(n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.

(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.

Outcomes

Primary Outcome Measures

BMI
Only in the obese/overweight population. Change in body mass index (Kg/m2)
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.
Concentration of interstitial glucose
Only in the obese/overweight population. Change in Interstitial Glucose (mgl/dl) measured continuously with the Freestyle glucometer (Abbott Laboratories)
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.

Secondary Outcome Measures

Weight
Weight change (Kg)
WC
Change in waist circumference (cm)
Body composition
Change in % of fat mass
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Faecal microbiota
Faecal microbiota taxonomic profiling through shotgun sequencing.
Gut dysbiosis
Lipopolysaccharide-binding protein (LBP) levels as an indirect measure of intestinal dysbiosis.
Genotype
Genotyping of single nucleotide genetic variants (SNPs) and specific mutations associated with metabolism, nutrition and immunodegenerative processes.
Gene expression
Expression panels in genes related to the regulation of metabolism, inflammation, immunity, oxidation, nutrition and immunodegenerative processes.

Full Information

First Posted
February 27, 2023
Last Updated
March 28, 2023
Sponsor
IMDEA Food
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1. Study Identification

Unique Protocol Identification Number
NCT05807243
Brief Title
Description of Immunosenescence Biomarkers and Nutritional Intervention to Evaluate the Implementation of Digital Tools
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IMDEA Food

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Artificial Intelligence, Multi-modal learning, Nutrition, Biomarkers, Precision Nutrition, Immunosenescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Traditional → Digital)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 (Digital → Traditional)
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 3 - Young healthy population
Arm Type
No Intervention
Arm Description
n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.
Arm Title
Group 4 - Senior population
Arm Type
No Intervention
Arm Description
n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.
Arm Title
Group 5 - Oncological population
Arm Type
No Intervention
Arm Description
(n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.
Arm Title
Group 6 - COVID-19 population
Arm Type
No Intervention
Arm Description
(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.
Intervention Type
Other
Intervention Name(s)
Dietary intervention for healthy weight loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI
Description
Only in the obese/overweight population. Change in body mass index (Kg/m2)
Time Frame
1 month
Title
Blood Glucose
Description
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.
Time Frame
1 month
Title
Concentration of interstitial glucose
Description
Only in the obese/overweight population. Change in Interstitial Glucose (mgl/dl) measured continuously with the Freestyle glucometer (Abbott Laboratories)
Time Frame
15 days
Title
Blood lymphocytes
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight
Description
Weight change (Kg)
Time Frame
1 month
Title
WC
Description
Change in waist circumference (cm)
Time Frame
1 month
Title
Body composition
Description
Change in % of fat mass
Time Frame
1 month
Title
Blood pressure
Description
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.
Time Frame
1 month
Title
Heart Rate
Description
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.
Time Frame
1 month
Title
Dietary intake
Description
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.
Time Frame
1 month
Title
Physical activity
Description
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.
Time Frame
1 month
Title
Sleep
Description
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.
Time Frame
1 month
Title
Mental health state
Description
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.
Time Frame
1 month
Title
Cognition
Description
Measured via the validated Mini-mental state examination (MMSE). In the Mini-mental state examination, the higher the score, the better the cognitive status.
Time Frame
1 month
Title
Health status and quality of life
Description
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.
Time Frame
1 month
Title
Percentage of glycated haemoglobin
Description
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.
Time Frame
1 month
Title
Total cholesterol
Description
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.
Time Frame
1 month
Title
Low density lipoprotein (LDL)
Description
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.
Time Frame
1 month
Title
High density lipoprotein (HDL)
Description
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.
Time Frame
1 month
Title
Triglycerides
Description
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.
Time Frame
1 month
Title
Apo A1
Description
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.
Time Frame
1 month
Title
Apo B
Description
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.
Time Frame
1 month
Title
Insulin
Description
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.
Time Frame
1 month
Title
Glycated hemoglobin (HbA1c)
Description
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.
Time Frame
1 month
Title
Homeostatic model assessment (HOMA)
Description
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.
Time Frame
1 month
Title
Albumin
Description
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.
Time Frame
1 month
Title
Prealbumin
Description
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.
Time Frame
1 month
Title
C-reactive protein (CRP)
Description
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.
Time Frame
1 month
Title
Leptin
Description
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.
Time Frame
1 month
Title
Adinopectin
Description
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.
Time Frame
1 month
Title
Faecal microbiota
Description
Faecal microbiota taxonomic profiling through shotgun sequencing.
Time Frame
1 month
Title
Gut dysbiosis
Description
Lipopolysaccharide-binding protein (LBP) levels as an indirect measure of intestinal dysbiosis.
Time Frame
1 month
Title
Genotype
Description
Genotyping of single nucleotide genetic variants (SNPs) and specific mutations associated with metabolism, nutrition and immunodegenerative processes.
Time Frame
1 month
Title
Gene expression
Description
Expression panels in genes related to the regulation of metabolism, inflammation, immunity, oxidation, nutrition and immunodegenerative processes.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (commun for all groups): 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: 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. Exclusion Criteria: 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Ramírez de Molina, PhD
Organizational Affiliation
Fundación IMDEA Alimentación
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrique Carrillo de Santa Pau, PhD
Organizational Affiliation
Fundación IMDEA Alimentación
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María Isabel Espinosa Salinas, PhD
Organizational Affiliation
Fundación IMDEA Alimentación
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristina María Fernández Díaz, PhD
Organizational Affiliation
Fundación IMDEA Alimentación
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMDEA Food
City
Madrid
ZIP/Postal Code
28049
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25815989
Citation
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.
Results Reference
background
PubMed Identifier
30954305
Citation
GBD 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. Erratum In: Lancet. 2021 Jun 26;397(10293):2466.
Results Reference
background
PubMed Identifier
32468984
Citation
Moore 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.
Results Reference
background
Links:
URL
https://www.food.imdea.org/research/precision-nutrition-programs/program-cancer
Description
Research team profile
URL
https://www.food.imdea.org/computational-biology
Description
Research team profile
URL
https://www.food.imdea.org/services/Platform-Clinical-Trials-Nutrition-and-Health
Description
Research team profile

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Description of Immunosenescence Biomarkers and Nutritional Intervention to Evaluate the Implementation of Digital Tools

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