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Completed

NCT Number: NCT06661330

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

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.

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Key information

Conditions

Diet Therapy Behavior Body Composition Changes Mediterranean Diet Motor Activity Physical Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department for the Promotion of Human Science and Quality of Life San Raffaele Open University

Rome, 00166, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Treatment

Other

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

San Raffaele Telematic University

Other

Registry information

Acronym: GENDIET

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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