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NCT07461870Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 10 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
54 (actual)
First submitted
20 Jan 2026
Start date
9 Dec 2025
Primary completion date
8 Feb 2026
Lead sponsor
Universitas Indonesia
Diseases
Obesity
NCT number
NCT07461870

What you commit to

  • Study type: Interventional
  • Participants enrolled: 54
  • From 9 Dec 2025 to the primary completion date, 8 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking medications with hyperglycemic effects, such as beta-blockers, thiazides, corticosteroids, calcineurin inhibitors, anti-dyslipidemic medications (e.g., statins, fibrates, niacin, and bile acid sequestrants), or antibiotics.

Other illness

  • Subjects with a history of type 2 diabetes, kidney disease, liver disease, or thyroid disorders, as indicated by medical history or medical records.
  • Contraindications for the MF-BIA examination include the use of pacemakers or implants and a history of amputation.
  • History of food allergies

Other

  • Pregnant or within 40 days of childbirth
  • Adults with edema

Who the study is looking for

  • Women who were obese, as defined by a BMI of at least 27.
  • Aged 18-50 years
  • Subjects with a non-shift work schedule
  • Willing to follow the research procedures and sign the informed consent form.

Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Nutrition, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia
Coordinator of this site? Confirm its status
Jakarta PusatIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.