Clinical trial NCT06661330: Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters
Official title: Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Therapy
Mediterranean Diet
Body Composition Changes
Physical Activity
Keywords: Metabolic parameters
Mediterranean diet
Physical activity
Body composition
Lipid profiles
Gender differences
Lead sponsor: San Raffaele Telematic University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body Composition (Fat Mass and Lean Mass)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Fasting Glucose
timeFrame: Baseline and 6 months
measure: Change in Lipid Profiles (HDL, LDL, Total Cholesterol, Triglycerides)
timeFrame: Baseline and 6 months
measure: Change in Creatinine Levels
timeFrame: Baseline and 6 months
measure: Change in Liver Enzymes (AST, ALT)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department for the Promotion of Human Science and Quality of Life San Raffaele Open University
Study officials:
affiliation: Department for the Promotion of Human Science and Quality of Life San Raffaele Open University, Rome
name: Massimiliano Caprio, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.