Body Composition Changes, Diet Therapy, Mediterranean Diet, Physical Activity
Conditions
Keywords
Metabolic parameters, Mediterranean diet, Physical activity, Body composition, Lipid profiles, Gender differences
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.
Interventions
OTHERBehavioral Treatment
Participants 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
Sponsors
San Raffaele Telematic University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed