Prevention of accelerated aging in subjects with overweight or obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
A randomized, controlled clinical trial of a combined lifestyle intervention will be conducted. It will be a parallel trial in which people will be randomized 1:1 to the intervention group or the cont
reduce tobacco consumption
increase the days of time-restricted eating (increasing the days by following an 8-hour eating and 16-hour fasting schedule, adapted to their schedules)
increase/decrease sleep hours to have a healthy recommendation adapted to age (7 to 9 hours) and improve sleep quality
and an intervention will also be carried out to reduce stress levels. Specialized personnel, including registered dietitians for dietary interventions, psychologists for stress reduction interventions
Sponsors
University of Valencia
CIBEROBN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteers from the general population 2. Overweight or obese (Body Mass Index (BMI >=25 kg/m2 and less than 40 kg/m2) 3. Aged from 20 to 85 years old 4. With at least one other risk factor related to aging (sedentary, low adherence to the Mediterranean Diet, smoker, unhealthy sleep patterns or very frequent eating patterns) 5. Caucasian origin of the Spanish population 6. 50% women
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Diabetes type 1 or 2 3. Taking medications to lose weight 4. Consumption of psychoactive substances or alcohol abuse. 5. Existing cardiovascular diseases, active cancer, active infections and other acute diseases (respiratory, intestinal, liver, kidney) 6. Allergies or problems related to the interventions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DNA methylation (epigenomic biomarker of aging) in isolated blood measured using the EPIC v.2 Illumina array at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Omics biomarkers, including metabolomics (measured in plasma/serum by magnetic nuclear resonance), transcriptomics (measured in RNA isolated from blood and analyzed with a human transcriptome array), proteomics (measured in blood in a subsample), and metagenomics (measured in DNA from feces in a subsample using metatatoxonomics), at 6 months 2. Epigenomics and the other biomarkers (in a subsample) measured using the described methods at baseline and 3 months 3. The effects on aging markers and cardiometabolic health parameters after a year of follow-up (6 months intervention and 6 months after the intervention and after the combined intervention) using the same methodology for the omics analysis. 4. Association with cardiometabolic health parameters, including antropometric parameters (weight, % fat mass measured by bioimpedance, waist circumference), biochemical parameters (fasting glucose, plasma lipids, liver function biomarkers, kidney function biomarkers, measured by standard procedures) and autophagy biomarkers (polyamines, reporters in isolated leukocytes in a subsample). In addition, chronotype (MEQ questionnaire), cognitive function (by validated tests including minimental, fluency test and spacial memory tests) at 6 months and at 3 and 12 months in a subsample. 5. The main lifestyle variables associated with the combined intervention consisting on diet (adherence to the Mediterranean diet measured by the MEDAS-14 and MEDAS-17 validated questionnaire and food frequency questionnaires), physical activity (measured by validated questionnaires and accelerometers in a subsample), healthy sleep (sleep duration and quality measured by validated questionnaires), tobacco consumption, stress (measured by validated questionnaires), and restricted meal time (measured by specific time-restricted questionnaires and 24h-recalls including timing of foods) from baseline to 6 months of intervention compared to the control group. These parameters will also be measured at | — |
Countries
Spain
Contacts
Public ContactDolores Corella
Outcome results
None listed