- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07423884
Effect of a Low-Calorie MCT-Rich Traditional Minangkabau Diet on Obese Individuals
The Effect of a Low-Calorie Diet Rich in Medium-Chain Triglycerides Based on Traditional Minangkabau Foods on Lipid Profile, Leptin Levels, and DNA Methylation of the Leptin Gene Promoter in Individuals With Obesity
Study Overview
Status
Detailed Description
This study was conducted within the Faculty of Medicine and the Faculty of Public Health at Andalas University, Padang, and received ethical approval from the Research Ethics Committee of the Faculty of Medicine, Andalas University. The study population consisted of educational staff with a body mass index (BMI) greater than 25 kg/m². Study participants were educational staff who agreed to participate and provided written informed consent. A total of 40 participants were included in the study, comprising 20 participants in the intervention group and 20 participants in the control group.
The study was conducted over a period of 12 weeks (90 days). One week prior to the intervention, dietary intake was assessed using the 24-hour food recall method. Anthropometric measurements were performed using calibrated instruments by trained personnel.
Participants in both the intervention and control groups underwent a one-week pre-intervention period (baseline period, from day -6 to day 0), during which they were instructed not to consume any supplements. Anthropometric measurements, blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter were assessed on day 0 and day 90.
Dietary intake data obtained from the 24-hour food recall interviews were analyzed using the NutriSurvey 2005 software. The dietary intervention was designed to provide an energy deficit of 500-600 kcal compared with participants' habitual daily intake. The diet was based on traditional Minangkabau foods.
Participants in the intervention group were provided with daily menu plans for breakfast, lunch, and dinner. The dietary intervention was prepared independently by participants in accordance with the dietary guidelines and menus provided. In contrast, the control group followed a standard nutritionally balanced diet according to individual requirements. Participants were instructed to record their daily food intake in a food diary, which was collected and evaluated twice weekly (on weekdays and weekends). In addition, the research team monitored and motivated all participants through WhatsApp groups. Data analysis was performed using SPSS software.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nur Indrawaty Lipoeto, Professor
- Phone Number: +6281275950763
- Email: indralipoeto@med.unand.ac.id
Study Contact Backup
- Name: Nola Vita Sari
- Phone Number: +62823 8911-0304
- Email: 2430312022_nola@student.unand.ac.id
Study Locations
-
-
West Sumatera
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Padang, West Sumatera, Indonesia
- Prof. Nur Indrawaty Lipoeto
-
Contact:
- Lipoeto, Professor
- Phone Number: +6281275950763
- Email: indralipoeto@med.unand.ac.id
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Administrative staff of the Faculty of Medicine and the Faculty of Public Health, Andalas University, Padang, with obesity defined as a body mass index (BMI) ≥ 25 kg/m².
- Willing to participate in the study by providing written informed consent.
- Participants with obesity classified as Metabolically Unhealthy Obese (MUHO)
Exclusion Criteria:
- Did not come and could not be found at the time of research data collection
- Unable to follow the dietary arrangements as set
- Taking anti-diabetic or anti-lipid drugs
- Use of contraceptives or hormonal drugs
- In the treatment of radiotherapy or chemotherapyi
- Participants with obesity classified as Metabolically Healthy Obese (MHO)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group (low-calorie diet rich in medium-chain triglycerides [MCTs] based on traditiona
Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods Participants in the intervention group received a nutritionally balanced low-calorie diet rich in medium-chain triglycerides (MCTs) derived from traditional Minangkabau foods.
The dietary intervention was designed to provide an energy deficit of 500-600 kcal compared with participants' habitual daily intake.
Assessments were conducted before and after the intervention period.
|
Participants in the intervention group received a nutritionally balanced low-calorie diet rich in medium-chain triglycerides (MCTs) derived from traditional Minangkabau foods.
The dietary intervention was designed to provide an energy deficit of 500-600 kcal compared with participants' habitual daily intake.
Assessments were conducted before and after the intervention period.
|
|
No Intervention: Control group (standard nutritionally balanced diet)
Standard Nutritionally Balanced Diet Participants in the control group received a standard nutritionally balanced diet without specific emphasis on MCT content.
This diet was not designed to induce an energy deficit and was instead tailored to participants' usual daily dietary habits and energy requirements.
Assessments were conducted before and after the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in body mass index (BMI).
Time Frame: After 12 weeks
|
BMI is calculated as body weight in kilograms divided by the square of height in meters (kg/m²).
|
After 12 weeks
|
|
Change from baseline in waist circumference.
Time Frame: After 12 weeks
|
Waist circumference is measured around the abdomen at the level of the umbilicus.
|
After 12 weeks
|
|
Change from baseline in body fat percentage
Time Frame: After 12 weeks
|
Body fat percentage is assessed using bioelectrical impedance analysis (BIA).
|
After 12 weeks
|
|
Change from baseline in systolic and diastolic blood pressure
Time Frame: After 12 weeks
|
Blood pressure is measured using a digital tensimeter.
|
After 12 weeks
|
|
Change from baseline in fasting blood glucose levels.
Time Frame: After 12 weeks
|
Fasting blood glucose levels are measured using a clinical chemistry analyzer.
|
After 12 weeks
|
|
Change from baseline in lipid profile.
Time Frame: After 12 weeks
|
The lipid profile includes total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol.
Measurements are performed using a clinical chemistry analyzer (photometer).
|
After 12 weeks
|
|
Change from baseline in serum leptin.
Time Frame: After 12 weeks
|
Serum leptin concentrations are measured using appropriate laboratory methods (ELISA).
|
After 12 weeks
|
|
Change from baseline in DNA methylation of the leptin gene promoter.
Time Frame: After 12 weeks
|
DNA methylation status of the leptin gene promoter is assessed using MSP (Methylation-Specific PCR).
|
After 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in metabolic status.
Time Frame: After 12 weeks
|
Metabolic status is classified into Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUHO) based on the number of metabolic abnormalities present.
|
After 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nur Indrawaty Lipoeto, Professor, Universitas Andalas
Publications and helpful links
General Publications
- Lipoeto, N.I., Elliyanti, A. and Febri, D.S. (2025) 'The Effect of A Low-Calorie Balanced Nutrition Diet Based on Minang Cuisine in Obese Patients', 10(February), pp. 26-34.
- Lipoeto, N.I., Agus, Z., Oenzil, F., Wahlqvist, M.L. and Wattanapenpaiboon, N. (2004) 'Dietary intake and the risk of coronary heart disease among the coconut-consuming Minangkabau in West Sumatra, Indonesia', Asia Pacific Journal of Clinical Nutrition, 13(4), pp. 377-384.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Hyperinsulinism
- Overweight
- Lipid Metabolism Disorders
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Diabetes Mellitus
- Insulin Resistance
- Dyslipidemias
Other Study ID Numbers
- PMDSU2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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