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The Mediterranean Diet Based on Local Foods for Obese Patients

NCT07461870 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-02-08
Completion
2026-02-28

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07461870 on ClinicalTrials.gov