NCT06857929Recruiting
"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the effect of a multifactorial lifestyle intervention combining Mediterranean diet, energy reduction and physical activity on weight loss in middle-aged adults (men and women 30-50 years old) with metabolic syndrome. The main questions it aims to answer are: Is a multifactorial intervention based on Mediterranean diet, energy reduction and physical activity able to promote weight loss maintenance in middle-aged men and women with metabolic syndrome? syndrome? Which are the sociodemographic barriers to adhere to a multifactorial lifestyle intervention to promote cardiometabolic health? How is the lifestyle pattern of middle-aged Spanish adults with metabolic Researchers will compare a multifactorial lifestyle intervention combining Mediterranean diet, energy reduction and physical activity to a control intervention based on usual primary healthcare to see if the intervention improve cardiometabolic traits and promote weight loss maintenance after 1 year. Participants in the intervention arm will be asked to follow an energy-reduced Mediterranean diet plus a physical activity program with the aim of reducing 5-10% of the initial weight in 6 months and of maintaining the weight lost after 1 year o follow-up.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- IMDEA Food
- Diseases
- Obesity
- NCT number
- NCT06857929
What you commit to
- Study type: Interventional
- Planned participants: 106
- From 1 Mar 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have a diagnosed illness that interferes with the recommendations proposed in the intervention.
- Serious psychiatric illness/disorder.
Other
- Women with established menopause.
- Pregnant or breastfeeding women.
- 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.
Who the study is looking for
- 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
Age in the registry: 30 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IMDEA Nutrition Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.