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Effects of Three Dietary Strategies on Body Composition and Metabolic Health in Adults With Overweight or Obesity

NCT07314177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-02

No results posted yet for this study

Summary

This study aims to compare the effects of three dietary interventions-a traditional Mediterranean diet, a Mediterranean low-carbohydrate diet, and a high-protein diet-on body composition, metabolic health markers, and metabolic syndrome remission in adults with overweight or obesity. A total of 45 participants will be randomly assigned to one of the three diets for 12 weeks, with regular follow-up by dietitians. Measurements will include weight, body fat, muscle mass, waist and hip circumference, blood pressure, and blood tests to assess glucose, cholesterol, inflammation, and other metabolic parameters. The findings will help determine whether one dietary pattern is more effective than others in improving short-term health outcomes in this population.

Conditions

  • Overweight (BMI > 25)
  • Obesity &Amp; Overweight
  • Metabolic Syndrome (MetS)
  • Cardiometabolic Risk Factors

Interventions

OTHER

Mediterranean Diet

A traditional Mediterranean diet providing approximately 55% of total energy from carbohydrates, 15% from protein, and 30% from fats. Emphasizes whole grains, vegetables, fruits, legumes, nuts, olive oil, moderate fish and poultry, and limited red meat, processed foods, and added sugars. Energy intake adjusted to achieve a 20-25% caloric deficit.

OTHER

Mediterranean Low-Carbohydrate Diet

A Mediterranean-style diet with reduced carbohydrate content (40% of total energy from carbohydrates, 25% from protein, and 35% from fats). Retains core Mediterranean foods while limiting bread, pasta, rice, and other high-carb foods. Energy intake adjusted to achieve a 20-25% caloric deficit.

OTHER

High-Protein Diet

A high-protein dietary pattern providing approximately 30% of total energy from carbohydrates, 40% from protein, and 30% from fats. Includes lean meats, poultry, fish, eggs, low-fat dairy, vegetables, nuts, and olive oil, with limited refined carbs and added sugars. Energy intake adjusted to achieve a 20-25% caloric deficit.

Sponsors & Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-08
Primary Completion
2025-04-20
Completion
2025-06-25

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314177 on ClinicalTrials.gov