NCT07461870

The Mediterranean Diet Based on Local Foods for Obese Patients

The Mediterranean Diet Based on Local Foods for Obese Patients: A Study of Anthropometric Parameters, Inflammatory Markers, and Gut Microbiota

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to examine the efficacy of a Mediterranean diet based on local Indonesian foods on alterations in gut microbiota, body composition, and metabolic biomarkers in obese subjects. The main questions it aims to answer are: Dose Mediterranean diet modification based on local food ingredients can result in greater weight loss, greater reductions in inflammatory markers, improve gut microbiota diversity compared to a balanced low-calorie diet in obese patients? Researchers will compare Mediterranean diet modification based on local food to low calorie diet. Participant will: * Participants received a low-calorie diet of approximately 1.500 kcal/day according to their randomized group assignments, consisting of breakfast, lunch, dinner, and snacks. Both groups will receive dietary education and physical activity guidance tailored to their weight loss needs. * Participants were instructed to complete a food intake record and report their consumption to the researchers using intake forms and photographs of the food packaging. Weekly meetings were held via Zoom to evaluate dietary compliance. * Blood samples and fecal specimens were collected at baseline (week 0) and at week 4 of the study.

Conditions

• Obese Subjects

Interventions

Type	Name	Description
OTHER	Locally Adapted Mediterranean Diet	In the interventional group, participants received a locally adapted Mediterranean diet providing approximately 1,500 kcal/day, with a macronutrient distribution of 50% carbohydrates, 30-34% fat (saturated fatty acids ≤ 8%, monounsaturated fatty acids 15-20%, polyunsaturated fatty acids 5-10%), and 17-20% protein.
OTHER	Low calorie diet	In the control group, Participants received a low calorie diet providing approximately 1,500 kcal/day, the diet provided 50-54% carbohydrates, 25-30% fat (SFA \< 12%, MUFA 8-12%, PUFA 5-8%), and 19-20% protein.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-02-08
• Completion: 2026-02-28
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Indonesia