Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diet Therapy
- Sponsor
- San Raffaele Telematic University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in Body Composition (Fat Mass and Lean Mass)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Mauro Lombardo
Associate professor
San Raffaele Telematic University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in Body Composition (Fat Mass and Lean Mass)
Time Frame: 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 Outcomes
- Change in Fasting Glucose(Baseline and 6 months)
- Change in Lipid Profiles (HDL, LDL, Total Cholesterol, Triglycerides)(Baseline and 6 months)
- Change in Creatinine Levels(Baseline and 6 months)
- Change in Liver Enzymes (AST, ALT)(Baseline and 6 months)