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

NCT06661330 | Completed

• 1 other identifier: Gender_Diet_2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metabolic parameters; Mediterranean diet; Physical activity; Body composition; Lipid profiles; Gender differences

Outcome Measures

Primary Outcomes (1)

• Change in Body Composition (Fat Mass and Lean Mass)

  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 Outcomes (4)

• Change in Fasting Glucose

  Baseline and 6 months

• Change in Lipid Profiles (HDL, LDL, Total Cholesterol, Triglycerides)

  Baseline and 6 months

• Change in Creatinine Levels

  Baseline and 6 months

• Change in Liver Enzymes (AST, ALT)

  Baseline and 6 months

Study Arms (1)

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

Interventions

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

Mediterranean Diet Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults aged 18 years and older.
• Able to follow a Mediterranean diet and participate in physical activity.
• Provide informed consent.

You may not qualify if:

• Pregnant women.
• Individuals with severe chronic diseases.
• Participants with alcohol or substance abuse.

Sponsors & Collaborators

• San Raffaele Telematic University: lead

Study Sites (1)

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

Rome, 00166, Italy

Location

Related Publications (4)

• Manzano-Carrasco S, Felipe JL, Sanchez-Sanchez J, Hernandez-Martin A, Clavel I, Gallardo L, Garcia-Unanue J. Relationship between Adherence to the Mediterranean Diet and Body Composition with Physical Fitness Parameters in a Young Active Population. Int J Environ Res Public Health. 2020 May 11;17(9):3337. doi: 10.3390/ijerph17093337.

  PMID: 32403376 BACKGROUND

• Barrea L, Verde L, Suarez R, Frias-Toral E, Vasquez CA, Colao A, Savastano S, Muscogiuri G. Sex-differences in Mediterranean diet: a key piece to explain sex-related cardiovascular risk in obesity? A cross-sectional study. J Transl Med. 2024 Jan 10;22(1):44. doi: 10.1186/s12967-023-04814-z.

  PMID: 38200498 BACKGROUND

• Gorini S, Camajani E, Cava E, Feraco A, Armani A, Amoah I, Filardi T, Wu X, Strollo R, Caprio M, Padua E, Lombardo M. Gender differences in eating habits and sports preferences across age groups: a cross-sectional study. J Transl Med. 2025 Mar 12;23(1):312. doi: 10.1186/s12967-025-06311-x.

  PMID: 40075461 DERIVED

• Gorini S, Camajani E, Feraco A, Armani A, Karav S, Filardi T, Aulisa G, Cava E, Strollo R, Padua E, Caprio M, Lombardo M. Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters. Nutrients. 2025 Jan 20;17(2):354. doi: 10.3390/nu17020354.

  PMID: 39861484 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Massimiliano Caprio, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: January 2, 2024
• Primary Completion: August 31, 2024
• Study Completion: October 1, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

IT (1)