Calorie-reduced Mediterranean diet plus activity program to lower chronic disease risk in 30–50-year-olds
Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
This program will try a 25% calorie-reduced Mediterranean diet combined with increased physical activity to help 30–50-year-olds with metabolic syndrome lose weight and improve cardiometabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | All |
| Sponsor | IMDEA Food Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06857929 on ClinicalTrials.gov |
What this trial studies
This interventional program compares a multifactorial lifestyle intervention—an energy-reduced Mediterranean diet (about 25% caloric restriction) plus a structured physical activity program—to usual primary care in middle-aged adults with metabolic syndrome. Participants are men and women aged roughly 30–50 years with BMI 27–40 kg/m2 and stable recent weight, enrolled at IMDEA Nutrition in Madrid. The intervention is delivered within the primary care framework and targets weight loss maintenance, improvements in blood pressure, glucose, and lipid measures, and identification of sociodemographic barriers to adherence. Outcomes include weight change, cardiometabolic trait changes, adherence measures, and progression through stages of behavior change.
Who should consider this trial
Good fit: Adults aged 30–50 with BMI 27–40 kg/m2 who meet diagnostic criteria for metabolic syndrome, have had stable weight in the prior 3 months, and are able to follow diet and physical activity recommendations.
Not a fit: People outside the specified age or BMI ranges, women with established menopause, pregnant or breastfeeding women, those with serious psychiatric illness or medical conditions that prevent following the program, or individuals with low likelihood of adherence are unlikely to benefit.
Why it matters
Potential benefit: If successful, the intervention could help participants maintain weight loss and improve blood pressure, blood glucose, and cholesterol, thereby lowering future risk of diabetes and cardiovascular disease.
How similar studies have performed: Previous trials of Mediterranean-style diets and increased physical activity have demonstrated improvements in weight and cardiometabolic risk, though delivering a formal 25% energy restriction within primary care for weight-loss maintenance is less frequently tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI 27-40 Kg/m2 * Metabolic syndrome according to International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity * Stable weight in the last 3 months (weight changes \< 4Kg) * Be able to give informed consent Exclusion Criteria: * Have a diagnosed illness that interferes with the recommendations proposed in the intervention. * Women with established menopause. * Pregnant or breastfeeding women. * Serious psychiatric illness/disorder. * Social, cultural or psychological factors that may affect adherence to the intervention protocol. * Inability to communicate with study staff. * Inability to follow recommended diet or inability to engage in physical activity. * Low likelihood of modifying dietary habits according to the different stages of change according to the Prochaska and DiClemente model. * Difficulty attending scheduled appointments within the intervention due to work schedule conflicts, travel plans, scheduled surgeries, among other reasons. * Therapeutic non-compliance. * Participating in a professionally-led nutritional intervention. * Being under medical treatment that affects weight, intake or energy expenditure in the 3 months preceding the start of the study. Smokers who have changed their smoking habit in the 6 months preceding the start of the study (including starting or stopping smoking). \- Participation in another trial that may interfere with this proposed study.
Where this trial is running
Madrid, Madrid
- IMDEA Nutrition — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Lidia Daimiel Ruiz, Senior Researcher — IMDEA Food
- Study coordinator: Lidia Daimiel Ruiz, Senior Researcher
- Email: lidia.daimiel@alimentacion.imdea.org
- Phone: +34917278100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.