Diet and Exercise Program Tested in Middle-Aged Adults With Metabolic Syndrome
Tests a reduced-calorie Mediterranean diet with exercise in adults with metabolic syndrome.
Plain-language title generated from the registry record
Registry title: "Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Key facts
- Where
- Madrid, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 50 years old?
Source: NCT06857929, who can take part
Where in Spain
- IMDEA NutritionMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IMDEA Food
- Trial code
- NCT06857929
- Record updated
- 27 March 2026
- Original description
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:Read full original descriptionShow less
Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
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.
Inclusion: 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: Have a diagnosed illness that interferes with the recommendations proposed in the intervention; Serious psychiatric illness/disorder; 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.