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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Glucose | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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The study includes 200 adults from a metabolic health clinic in Rome, Italy, participating in a 6-month Mediterranean diet and physical activity intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Massimiliano Caprio, PhD | Department for the Promotion of Human Science and Quality of Life San Raffaele Open University, Rome | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for the Promotion of Human Science and Quality of Life San Raffaele Open University | Rome | 00166 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32403376 | Background | 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. | |
| 38200498 |
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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.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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 | 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) | The secondary outcome includes changes in liver enzymes (AST, ALT) measured at baseline and after the 6-month intervention. | Baseline and 6 months |
| 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. |
| 40075461 | Derived | 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. |
| 39861484 | 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. |