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RECRUITING
NCT06857929
NA

"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"

Sponsor: IMDEA Food

View on ClinicalTrials.gov

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

BEHAVIORAL

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.

BEHAVIORAL

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