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

San Raffaele Telematic University

Status: Completed

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

Treatments: Other: Behavioral Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06661330

Gender_Diet_2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Mediterranean Diet Intervention Group

Description:

This group consists of 200 adults who participated in a 6-month Mediterranean diet intervention combined with regular physical activity. The intervention focused on reducing energy intake by approximately 600 kcal/day while emphasizing plant-based foods, fish, and poultry. Participants' metabolic parameters, including body composition, fasting glucose, lipid profiles, and liver enzymes, were assessed at baseline and after 6 months.

Treatment:

Other: Behavioral Treatment