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

NCT06857929 | Recruiting

• 1 other identifier: IMD PI-071
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Obesity Prevention; Obesity and Overweight

Keywords

metabolic syndrome; Mediterranean diet; Caloric restriction; Physical activity; Weight loss; Weight; body composition

Outcome Measures

Primary Outcomes (2)

• Percentage of weight loss

  Weight loss measured as % from baseline weight with a calibrated scale

  6 months

• Percentage of weight loss maintenance

  Percentage of weight loss maintained after 1 year, measured by a calibrated scale

  12 months

Secondary Outcomes (4)

• Change in waist perimeter (cm)

  6 months

• Changes in tryglyceride level

  6 months

• Changes in fasting glucose levels

  6 months

• Changes in glycated hemoglobin

  6 months

Study Arms (2)

Control group (CG)

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Intervention Group (IG)

EXPERIMENTAL

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

Behavioral: energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program

Interventions

Usual Care BEHAVIORAL

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

Control group (CG)

energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program BEHAVIORAL

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.

Also known as: Multifactorial lifestyle intervention, energy-reduced mediterranean diet, Physical activity, Caloric restriction

Intervention Group (IG)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Have a diagnosed illness that interferes with the recommendations proposed in the intervention.
• Women with established menopause.
• Pregnant or breastfeeding women.
• Serious psychiatric illness/disorder.
• 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.

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

IMDEA Nutrition

Madrid, Madrid, 28049, Spain

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Overweight; Motor Activity; Weight Loss; Body Weight

Interventions

Caloric Restriction; Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lidia Daimiel Ruiz, Senior Researcher

  IMDEA Food

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lidia Daimiel Ruiz, Senior Researcher

CONTACT

+34917278100; lidia.daimiel@alimentacion.imdea.org

Laura Villanova, Predoctoral researcher

CONTACT

+34646351160; laura.villanova@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It is a randomized, controlled, single blinded, parallel group clinical trial aiming to evaluate the effect of a multifactorial intervention based on Mediterranean diet, energy reduction and physical activity on parameters of metabolic syndrome in middle-aged men and women.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The protocol and the statistical analysis plan will be made publicly available at study recruitment ends. The IPD will be made accessible to other researcher 2 years after the publication of the main study outcomes
• Access Criteria: Anonymised, coded data (sociodemographic, anthropometric, clinical and biochemical) may be accessible to other researchers only for non-profit scientific purposes and upon reasonable request to the principal investigator.

Locations

ES (1)