Metabolic Syndrome Clinical Trials

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Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
IMDEA Nutrition
RECRUITING
Madrid
Contact Information
Primary
Lidia Daimiel Ruiz, Senior Researcher
lidia.daimiel@alimentacion.imdea.org
+34917278100
Backup
Laura Villanova, Predoctoral researcher
laura.villanova@salud.madrid.org
+34646351160
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 106
Treatments
Active_comparator: Control group (CG)
The aim of this group is to serve as control comparator of the intervention. Participants allocated to this group will be asked to follow genera lifestyle recommendations included in the clinical guidelines for metabolic syndrome in primary healthcare settings
Experimental: Intervention Group (IG)
Participants in this group will be asked to follow an energy-reduced Mediterranean diet and a physical activity program with the aim of lossing 5-10% of the initial weight in 6 months
Related Therapeutic Areas
Sponsors
Leads: IMDEA Food

This content was sourced from clinicaltrials.gov