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

October 24, 2024 updated by: Mauro Lombardo, San Raffaele Telematic University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00166
        • Department for the Promotion of Human Science and Quality of Life San Raffaele Open University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study includes 200 adults from a metabolic health clinic in Rome, Italy, participating in a 6-month Mediterranean diet and physical activity intervention.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mediterranean Diet Intervention Group
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.
Other: Behavioral 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Glucose
Time Frame: Baseline and 6 months
The secondary outcome includes changes in fasting glucose measured at baseline and after the 6-month intervention.
Baseline and 6 months
Change in Lipid Profiles (HDL, LDL, Total Cholesterol, Triglycerides)
Time Frame: 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.
Baseline and 6 months
Change in Creatinine Levels
Time Frame: Baseline and 6 months
The secondary outcome includes changes in creatinine levels measured at baseline and after the 6-month intervention.
Baseline and 6 months
Change in Liver Enzymes (AST, ALT)
Time Frame: Baseline and 6 months
The secondary outcome includes changes in liver enzymes (AST, ALT) measured at baseline and after the 6-month intervention.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Raffaele Telematic University

Investigators

  • Study Director: Massimiliano Caprio, PhD, Department for the Promotion of Human Science and Quality of Life San Raffaele Open University, Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Gender_Diet_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The de-identified individual participant data (IPD) will be made available to researchers upon reasonable request. Data will be shared securely for the purpose of secondary research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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