Clinical Trials Directory

Trials / Completed

CompletedNCT06661330

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

Status
Completed
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
San Raffaele Telematic University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBehavioral TreatmentParticipants followed a 6-month hypocaloric Mediterranean-style diet, reducing energy intake by approximately 600 kcal/day. The diet emphasized fruits, vegetables, whole grains, and fish, while limiting red meat and processed foods. Additionally, participants were required to perform moderate physical activity, including 50 minutes of aerobic exercise, 3 times a wee

Timeline

Start date
2024-01-02
Primary completion
2024-08-31
Completion
2024-10-01
First posted
2024-10-28
Last updated
2024-10-28

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06661330. Inclusion in this directory is not an endorsement.