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NCT Number: NCT07461870

The Mediterranean Diet Based on Local Foods for Obese Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obese Subjects Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

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.

Primary outcomes

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

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

    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):

    • 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.
    • Waist-to-hip ratio (WHR) is calculated by dividing waist circumference (centimeters) by hip circumference (centimeters) and expressed as cm. (WHR = Waist / Hip)

Secondary outcomes

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

    Time frame: The data were collected at baseline (week 0)

    Age was recorded in years.

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

    Time frame: The data were collected at baseline (week 0)

    Information on underlying diseases was collected using a structured questionnaire.

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

    Time frame: The data were collected at baseline (week 0)

    Subjects' nutritional status was assessed and categorized based on body mass index (BMI) as obesity (≥27.0).

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

    Time frame: The data were collected at baseline (week 0)]

    Body composition was assessed using multi-frequency bioelectrical impedance analysis (MF-BIA) and included measurements of BMI, fat mass (in percentage), fat mass index (in percentage), energy stored in body (in Kilocalorie), Resting Energy Expenditure (in Kilocalorie), Total Energy Expenditure (in Kilocalorie), fat free mass (in percentage), Fat Free Mass Index, skeletal muscle mass (in percentage), Total Body Water (in percentage), Extra Cellular Water (in percentage), Bioelectrical Impedance Vector Analysis, visceral fat (in grams), dan phase angle.

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

    Time frame: The data were collected at baseline (week 0)

    Intake patterns were assessed using a questionnaire or food recall and reported in kcal.

  6. To determine the characteristics of the research subjects based on physical activity.

    Time frame: The data were collected at baseline (week 0)

    Global Physical Activity Questionnaire (GPAQ) to measure physical activity levels and sedentary behavior (Low: < 600 MET-minutes/week, Moderate: 600-3000 MET-minutes/week, High:≥ 3,000 MET-minutes/week)

  7. To determine the energy, protein, fat, and carbohydrate intake of research subjects before and after diet administration.

    Time frame: the data were collected at baseline (week 0) and at week 4 of the study.

    Energy (Kilocalorie), protein (in percentage), fat (in percentage), and carbohydrate (in percentage) intake were assessed using food recall and analyzed using NutriSurvey.

  8. To determine the differences in the mean anthropometry of the research subjects in each group.

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

    Differences in mean anthropometric parameters between the control (low-calorie diet) and intervention (locally adapted Mediterranean diet) groups were analyzed using an unpaired t-test.

    Anthropometric outcomes (ratio data scale):

    • 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.
    • Waist-to-hip ratio (WHR) is calculated by dividing waist circumference (centimeters) by hip circumference (centimeters) and expressed as cm. (WHR = Waist / Hip)

  9. To determine the differences the mean in nutritional status of the research subjects in each group.

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

    Differences in mean nutritional status between the control (low-calorie diet) and intervention (locally adapted Mediterranean diet) groups were analyzed using an unpaired t-test.

    Nutritional status (Ratio data scale) was categorized based on BMI as underweight (<18.5), normal (18.5-<25.0), overweight (25.0-<27.0), and obesity (≥27.0).

  10. To determine the differences in the mean body composition of the research subjects in each group.

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

    Differences in mean body composition between the control (low-calorie diet) and intervention (locally adapted Mediterranean diet) groups were analyzed using an unpaired t-test.

    Body composition was assessed using multi-frequency bioelectrical impedance analysis (MF-BIA) and included measurements of BMI, fat mass (in percentage), fat mass index (in percentage), energy stored in body (in Kilocalorie), Resting Energy Expenditure (in Kilocalorie), Total Energy Expenditure (in Kilocalorie), fat free mass (in percentage), Fat Free Mass Index, skeletal muscle mass (in percentage), Total Body Water (in percentage), Extra Cellular Water (in percentage), Bioelectrical Impedance Vector Analysis, visceral fat (in grams), dan phase angle.

  11. To determine changes and mean in IL-6 levels in research subjects before and after diet administration.

    Time frame: the data were collected at baseline (week 0) and at week 4 of the study.

    Changes in the mean levels of IL-6 before and after diet administration were analyzed using either a dependent t-test or the Wilcoxon signed-rank test, as appropriate.

    IL-6 (interleukin-6) levels were measured using 100 µL of blood plasma with the sandwich enzyme-linked immunosorbent assay (ELISA) method using a Human IL-6 ELISA Kit. IL-6 levels (nanograms/mililiter) are expressed on a ratio scale.

  12. To determine changes and mean in I-FABP levels in research subjects before and after diet administration.

    Time frame: the data were collected at baseline (week 0) and at week 4 of the study.

    Changes in the mean levels of I-FABP before and after diet administration were analyzed using either a dependent t-test or the Wilcoxon signed-rank test, as appropriate.

    Intestinal fatty acid-binding protein (I-FABP) concentrations were measured in 100 µL of plasma using a Human I-FABP ELISA Kit employing the sandwich ELISA method. I-FABP concentrations (nanograms/mililiter) are reported on a ratio scale.

  13. To determine changes and mean in TyG index levels in research subjects before and after diet administration.

    Time frame: the data were collected at baseline (week 0) and at week 4 of the study.

    Changes in the mean levels of TyG index before and after diet administration were analyzed using either a dependent t-test or the Wilcoxon signed-rank test, as appropriate.

    The triglyceride-glucose (TyG) index was calculated from 3 µL of plasma based on fasting triglyceride (TG) and fasting plasma glucose (FPG) concentrations using the following formula: ln [fasting TG (mg/dL) × FPG (mg/dL) / 2].

  14. To determine the effect of a locally adapted Mediterranean diet (intervention) and low calorie diet (control) on improving gut microbiota diversity in obese patients.

    Time frame: the data were collected at baseline (week 0) and at week 4 of the study.

    Gut Microbiota: Microbiota diversity (ratio data scale) Gut microbiota diversity was assessed from 250 mg of stool using the QIAGEN QIAamp PowerFecal Pro DNA Kit. DNA concentration and purity were determined by NanoDrop spectrophotometry and agarose gel electrophoresis

  15. To determine the effect of a locally adapted Mediterranean diet (intervention) and low calorie diet (control) on improving metabolomic profile in obese patients.

    Time frame: the data were collected at baseline (week 0) and at week 4 of the study.

    Metabolomic profiling (ratio data scale) was conducted on 100 µL of plasma using the Shimadzu GCMS-QP2020 NX system.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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