The Mediterranean Diet Based on Local Foods for Obese Patients

NCT07461870 | Active Not Recruiting

• 1 other identifier: 25-09-1322
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obesity; diet strategy; weight loss

Outcome Measures

Primary Outcomes (1)

• The implementation of a locally adapted Mediterranean has the potential to improve anthropometric outcomes profiles in obese.

  Title of the research is The Mediterranean Diet Based on Local Foods for Obese Patients: A Study of Anthropometric Parameters, Inflammatory Markers, and Gut Microbiota. Based on PRS review of each outcome the findings are described as follows: Anthropometric outcomes (ratio data scale): 1. Body mass index (BMI) will be calculated from weight (kilograms) and height (meters). Divide weight in kilograms (kilograms) by height in meters squared (meters²) expressed as kg/m². 2. Waist-to-hip ratio (WHR) is calculated by dividing waist circumference (centimeters) by hip circumference (centimeters) and expressed as cm. (WHR = Waist / Hip)

  The data were collected at baseline (week 0) and at week 4 of the study.

Secondary Outcomes (15)

• To determine the characteristics of the research subjects based on age.

  The data were collected at baseline (week 0)

• To determine the characteristics of the research subjects based on underlying disease.

  The data were collected at baseline (week 0)

• To determine the characteristics of the research subjects based on nutritional status.

  The data were collected at baseline (week 0)

• To determine the characteristics of the research subjects based on body composition.

  The data were collected at baseline (week 0)]

• To determine the characteristics of the research subjects based on intake patterns.

  The data were collected at baseline (week 0)

Study Arms (2)

Low calorie diet

ACTIVE COMPARATOR

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.

Other: Locally Adapted Mediterranean Diet

Locally Adapted Mediterranean Diet

EXPERIMENTAL

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

Interventions

Locally Adapted Mediterranean Diet OTHER

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.

Low calorie diet

Low calorie diet OTHER

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.

Locally Adapted Mediterranean Diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or within 40 days of childbirth
• Adults with edema
• 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.
• History of food allergies

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Department of Nutrition, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Links

• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info
• Related Info

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Clinical Nutrition Specialist

Model Details: * This study will be conducted using a single-blind randomized clinical trial design to evaluate the effects of a locally adapted Mediterranean diet intervention on anthropometric measures (BMI, WHR), body composition parameters (fat mass, fat-free mass, visceral fat), IL-6 levels, I-FABP levels, the TyG index, and gut microbiota composition. * The intervention group consists of obese patients who receive dietary education and a Mediterranean-based diet modification using local foods. The control group is composed of obese patients who will receive low calorie diet. * The study will be conducted at the Nutrition Clinic of Dr. Cipto Mangunkusumo Hospital (RSCM) and the Faculty of Medicine, Universitas Indonesia (FKUI), Jakarta.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: March 10, 2026
• Study Start: December 9, 2025
• Primary Completion: February 8, 2026
• Study Completion: February 28, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

ID (1)