NCT07314177

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

Comparative Effects of Three Dietary Strategies on Body Composition, Metabolic Markers, and Metabolic Syndrome in Adults With Overweight/Obesity: A Randomized Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER) · Other Government
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Detailed Description: This randomized, controlled, parallel-group pilot clinical trial will evaluate the effects of three different hypocaloric dietary strategies on body composition, metabolic markers, and metabolic syndrome remission in adults with overweight or obesity. Background and Rationale Overweight and obesity are highly prevalent in Europe and are associated with an increased risk of metabolic syndrome, cardiovascular disease, type 2 diabetes, and obesity-related cancers. Dietary interventions are a cornerstone in their management, but the optimal macronutrient composition for improving short-term metabolic outcomes remains unclear. This study investigates the comparative impact of a traditional Mediterranean diet, a Mediterranean low-carbohydrate diet, and a high-protein diet over a 12-week period. Study Design A total of 45 participants aged 18-65 years with a body mass index (BMI) ≥25 kg/m² will be recruited through online advertisements and primary care referrals. After eligibility screening and informed consent, participants will be randomly allocated (1:1:1) to one of the three dietary intervention arms. Intervention All diets will be hypocaloric, aiming for a 20-25% reduction in individual energy requirements, and will differ in macronutrient distribution: Mediterranean diet: 55% carbohydrates, 15% proteins, 30% fats. Mediterranean low-carbohydrate diet: 40% carbohydrates, 25% proteins, 35% fats. High-protein diet: 30% carbohydrates, 40% proteins, 30% fats. Participants will be followed biweekly by qualified dietitians through in-person or phone consultations. They will receive personalized meal plans, nutritional education, and support materials to enhance adherence. Assessments Anthropometric measures (BMI, fat mass, fat-free mass, waist and hip circumference) will be obtained at baseline and at 12 weeks using standardized protocols and validated equipment. Blood pressure will be measured with a calibrated automated device after a seated rest. Fasting blood samples will be collected in the morning for biochemical analyses, including glucose, HbA1c, insulin, lipid profile, uric acid, iron status, high-sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate, and liver enzymes. Outcomes The primary outcome is the change in BMI after 12 weeks. Secondary outcomes include changes in body composition, metabolic and inflammatory biomarkers, and the proportion of participants meeting the International Diabetes Federation (IDF) criteria for metabolic syndrome at baseline and post-intervention. Ethics and Dissemination The study protocol was approved by the Ethics Committee of Aragón (CEICA) (No. 13/2024) and will be conducted in accordance with the Declaration of Helsinki and current regulatory requirements. The findings will be disseminated through peer-reviewed publications and conference presentations.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-08
• Primary completion: 2025-04-20
• Completion: 2025-06-25
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: Spain