RecruitingNot ApplicableNCT06857929

"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

Sponsor

IMDEA Food

Enrollment

106 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity and Overweight Metabolic Syndrome Obesity Prevention

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.

Eligibility

Min Age: 30 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This randomized controlled trial is testing whether a 6-month structured lifestyle intervention — combining a calorie-reduced Mediterranean diet with a physical activity program — can produce meaningful and sustained weight loss in middle-aged adults (30 to 50 years old) with metabolic syndrome, compared to standard primary healthcare guidance. Metabolic syndrome — a cluster of conditions including high blood sugar, high blood pressure, abdominal obesity, and abnormal cholesterol — significantly raises the risk of heart disease and diabetes, and lifestyle change is a key treatment approach. Adults aged 30 to 50 with a BMI between 27 and 40, confirmed metabolic syndrome, and stable weight in the last 3 months are eligible, while those with significant illness interfering with the program, established menopause, pregnancy, serious psychiatric conditions, or current weight-loss programs are excluded. Participants will attend structured nutrition and exercise sessions, and follow-up will occur at 6 and 12 months to assess weight, metabolic markers, and cardiovascular health. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALenergy 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.

BEHAVIORALUsual 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

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NCT06857929

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