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Obese SubjectsNCT07461870

The Mediterranean Diet Based on Local Foods for Obese Patients

A study testing Locally Adapted Mediterranean Diet and Low calorie diet in people with Obese Subjects, run by Universitas Indonesia at 1 site in Indonesia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obese Subjects
What is being tested?
Locally Adapted Mediterranean Diet and Low calorie diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteIndonesia
Study dates
9 Dec 2025to 28 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Department of Nutrition, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia

    Jakarta Pusat, Jakarta Special Capital Region, 10430

Other trials in Indonesia

About this study

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

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?

Read more

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
Being tested
Locally Adapted Mediterranean Diet, Low calorie diet
Keywords
obesity, diet strategy, weight loss
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Locally Adapted Mediterranean DietOther

    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 dietOther

    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.

Study groups in NCT07461870
Study groupRoleWhat they receive
Low calorie dietActive comparatorIn 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.
Receives: Other: Locally Adapted Mediterranean Diet
Locally Adapted Mediterranean DietExperimentalIn 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.
Receives: Other: Low calorie diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (15)
  1. To determine the characteristics of the research subjects based on age.

    Age was recorded in years.

    Measured: The data were collected at baseline (week 0)

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

    Information on underlying diseases was collected using a structured questionnaire.

    Measured: The data were collected at baseline (week 0)

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

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

    Measured: The data were collected at baseline (week 0)

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

    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.

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

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

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

    Measured: The data were collected at baseline (week 0)

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

    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)

    Measured: The data were collected at baseline (week 0)

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

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

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

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

    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):

    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)

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

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

    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).

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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].

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

  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.

    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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start9 Dec 2025
  3. Primary completion8 Feb 2026
  4. Study completion28 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
* 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.
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07461870
Sponsor's protocol ID
25-09-1322
Status last verified
Mar 2026
First submitted
20 Jan 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Locally Adapted Mediterranean Diet and Low calorie diet in people with Obese Subjects, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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