Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters

Completed

• Conditions: Diet Therapy; Mediterranean Diet; Body Composition Changes; Physical Activity

• Registration Number: NCT06661330
• Lead Sponsor: San Raffaele Telematic University

Brief Summary

This study investigates the gender-specific effects of diet and physical activity on metabolic parameters in a cohort of adults. The study involved a 6-month intervention based on a Mediterranean-style diet and regular physical activity, with the primary objective of assessing changes in body composition, fasting glucose, lipid profiles, and liver enzymes. Participants were stratified by gender to evaluate whether men and women exhibit different metabolic responses to the intervention. The results aim to provide insights into personalized nutritional recommendations based on gender differences.

Detailed Description

The study was conducted to explore gender differences in metabolic responses to a Mediterranean-style diet combined with a structured physical activity regimen. The study population included 2,509 participants recruited from a metabolic health clinic in Rome, Italy. Participants followed a 6-month hypocaloric diet, with macronutrient distribution of 16% protein, 25% fats, and 59% carbohydrates. The diet emphasized plant-based foods, with limited red meat consumption and regular intake of fish and poultry. Alongside the dietary intervention, participants were instructed to perform moderate physical activity, including aerobic exercises for 50 minutes, three times a week.

Study Timeline

• Study Start: 2024-01-02
• Primary Completion: 2024-08-31
• Status Verified: 2024-10
• Study Completion: 2024-10-01
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults aged 18 years and older.
• Able to follow a Mediterranean diet and participate in physical activity.
• Provide informed consent.

Exclusion Criteria

• Pregnant women.
• Individuals with severe chronic diseases.
• Participants with alcohol or substance abuse.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Body Composition (Fat Mass and Lean Mass)	Baseline and 6 months	The primary outcome is the change in body composition, specifically fat mass and lean mass, after a 6-month Mediterranean diet intervention combined with regular physical activity.

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Glucose	Baseline and 6 months	The secondary outcome includes changes in fasting glucose measured at baseline and after the 6-month intervention.
Change in Lipid Profiles (HDL, LDL, Total Cholesterol, Triglycerides)	Baseline and 6 months	The secondary outcome includes changes in lipid profiles (HDL, LDL, total cholesterol, and triglycerides) measured at baseline and after the 6-month intervention.
Change in Creatinine Levels	Baseline and 6 months	The secondary outcome includes changes in creatinine levels measured at baseline and after the 6-month intervention.
Change in Liver Enzymes (AST, ALT)	Baseline and 6 months	The secondary outcome includes changes in liver enzymes (AST, ALT) measured at baseline and after the 6-month intervention.

Trial Locations

Locations (1)

Department for the Promotion of Human Science and Quality of Life San Raffaele Open University; 🇮🇹 Rome, Italy