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"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Sponsor: IMDEA Food
Summary
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.
Official title: Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
Key Details
Gender
All
Age Range
30 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2026-03-01
Completion Date
2028-09-30
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program
An intensive multifactorial lifestyle intervention involving monthly individual and group sessions during 6 months. Participants will be asked to follow a Mediterranean diet with a 25% reduction in energy and a physical activity program based on WHO recommendations to achieve a moderate physical activity level.
Usual Care
Participants in the control group will be asked to follow general recommendations to adhere to a healthy lifestyle, as indicated in the clinical guidelines of general practitioners and nurses for adults with metabolic syndrome
Locations (1)
IMDEA Nutrition
Madrid, Madrid, Spain