Metabolically Unhealty ObeseNCT07423884
Effect of a Low-Calorie MCT-Rich Traditional Minangkabau Diet on Obese Individuals
A study testing Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods in people with Metabolically Unhealty Obese and Dyslipidemia, run by Andalas University at 1 site in Indonesia.
Trial summary
This study aims to investigate the effect of a low-calorie diet rich in medium-chain triglycerides (MCTs) based on traditional Minangkabau foods on metabolic biomarkers in individuals with obesity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolically Unhealty Obese, Dyslipidemia, Diabetes (DM)
- What is being tested?
- Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2026to Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Prof. Nur Indrawaty Lipoeto
Padang, West Sumatera
Lipoeto, Professor, +6281275950763, indralipoeto@med.unand.ac.id
About this study
Official title: 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
This study aims to investigate the effect of a low-calorie diet rich in medium-chain triglycerides (MCTs) based on traditional Minangkabau foods on metabolic biomarkers in individuals with obesity. The traditional Minangkabau foods used in this study consist primarily of coconut milk-based dishes, which contain coconut oil as a natural source of MCTs. The metabolic biomarkers assessed include body mass index (BMI), waist circumference, systolic and diastolic blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter. Based on these metabolic biomarker measurements, participants will be classified into metabolic obesity phenotypes, namely metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The researchers hypothesize that the provision of a low-calorie, MCT-rich diet based on traditional Minangkabau foods will have a significant effect on metabolic biomarkers and metabolic status in individuals with obesity.
Read the 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.
- Being tested
- Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods
- Keywords
- Low-calorie diet rich in medium-chain triglycerides, Traditional Minangkabau foods, Coconut oil, Metabolic biomarkers, Anthropometric parameters
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau FoodsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (low-calorie diet rich in medium-chain triglycerides [MCTs] based on traditiona | Experimental | 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. Receives: Other: Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods |
| Control group (standard nutritionally balanced diet) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body mass index (BMI).
BMI is calculated as body weight in kilograms divided by the square of height in meters (kg/m²).
Measured: After 12 weeks
Change from baseline in waist circumference.
Waist circumference is measured around the abdomen at the level of the umbilicus.
Measured: After 12 weeks
Change from baseline in body fat percentage
Body fat percentage is assessed using bioelectrical impedance analysis (BIA).
Measured: After 12 weeks
Change from baseline in systolic and diastolic blood pressure
Blood pressure is measured using a digital tensimeter.
Measured: After 12 weeks
Change from baseline in fasting blood glucose levels.
Fasting blood glucose levels are measured using a clinical chemistry analyzer.
Measured: After 12 weeks
Change from baseline in lipid profile.
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).
Measured: After 12 weeks
Change from baseline in serum leptin.
Serum leptin concentrations are measured using appropriate laboratory methods (ELISA).
Measured: After 12 weeks
Change from baseline in DNA methylation of the leptin gene promoter.
DNA methylation status of the leptin gene promoter is assessed using MSP (Methylation-Specific PCR).
Measured: After 12 weeks
Secondary outcomes (1)
Change in metabolic status.
Metabolic status is classified into Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUHO) based on the number of metabolic abnormalities present.
- MHO is defined as the presence of 0-1 metabolic abnormality.
- MUHO is defined as the presence of ≥2 metabolic abnormalities. These metabolic abnormalities included elevated fasting blood glucose levels, increased blood pressure, enlarged waist circumference, elevated triglyceride levels, and reduced high-density lipoprotein (HDL) cholesterol levels.
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolically Unhealty ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Pre-post clinical trial * Intervention group (low-calorie diet rich in medium-chain triglycerides \[MCTs\] based on traditional Minangkabau foods) * Control group (standard nutritionally balanced diet)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andalas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nola Vita Sari, Andalas University
- Investigators
- Nur Indrawaty Lipoeto, Professor, Principal investigator, Universitas Andalas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423884
- Sponsor's protocol ID
- PMDSU2026
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 NI, Agus Z, Oenzil F, Wahlqvist M, Wattanapenpaiboon N. Dietary intake and the risk of coronary heart disease among the coconut-consuming Minangkabau in West Sumatra, Indonesia. Asia Pac J Clin Nutr. 2004;13(4):377-84.
PubMed 15563444
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07423884
- Acronym / sponsor ID
- PMDSU2026
- Keywords
- Low-calorie diet rich in medium-chain triglycerides, Traditional Minangkabau foods, Coconut oil, Metabolic biomarkers, Anthropometric parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Andalas UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of a low-calorie diet rich in medium-chain triglycerides (MCTs) based on traditional Minangkabau foods on metabolic biomarkers in individuals with obesity. The traditional Minangkabau foods used in this study consist primarily of coconut milk-based dishes, which contain coconut oil as a natural source of MCTs. The metabolic biomarkers assessed include body mass index (BMI), waist circumference, systolic and diastolic blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter. Based on these metabolic biomarker measurements, participants will be classified into metabolic obesity phenotypes, namely metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The researchers hypothesize that the provision of a low-calorie, MCT-rich diet based on traditional Minangkabau foods will have a significant effect on metabolic biomarkers and metabolic status in individuals with obesity.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-post clinical trial * Intervention group (low-calorie diet rich in medium-chain triglycerides [MCTs] based on traditional Minangkabau foods) * Control group (standard nutritionally balanced diet)
| Arm | Type | Receives |
|---|---|---|
| Intervention group (low-calorie diet rich in medium-chain triglycerides [MCTs] based on traditiona | Experimental | Other: Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau FoodsLow-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. |
| Control group (standard nutritionally balanced diet) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau FoodsParticipants 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. | Other | Intervention group (low-calorie diet rich in medium-chain triglycerides [MCTs] based on traditiona |
Primary outcome
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).
Change from baseline in waist circumference.
Time frame: After 12 weeks
Waist circumference is measured around the abdomen at the level of the umbilicus.
Change from baseline in body fat percentage
Time frame: After 12 weeks
Body fat percentage is assessed using bioelectrical impedance analysis (BIA).
Change from baseline in systolic and diastolic blood pressure
Time frame: After 12 weeks
Blood pressure is measured using a digital tensimeter.
Change from baseline in fasting blood glucose levels.
Time frame: After 12 weeks
Fasting blood glucose levels are measured using a clinical chemistry analyzer.
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).
Change from baseline in serum leptin.
Time frame: After 12 weeks
Serum leptin concentrations are measured using appropriate laboratory methods (ELISA).
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).
1 secondary outcome
Change in metabolic status.
Time frame: After 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- BackgroundLipoeto, 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.
- Background: PubMed 15563444Lipoeto NI, Agus Z, Oenzil F, Wahlqvist M, Wattanapenpaiboon N. Dietary intake and the risk of coronary heart disease among the coconut-consuming Minangkabau in West Sumatra, Indonesia. Asia Pac J Clin Nutr. 2004;13(4):377-84.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nur Indrawaty Lipoeto, Professor principal investigator
Universitas Andalas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods in people with Metabolically Unhealty Obese and Dyslipidemia, run by Andalas University 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 3 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: opening soon, as of the sponsor's last update on 13 Apr 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?
Contact Nur Indrawaty Lipoeto, Professor (+6281275950763, indralipoeto@med.unand.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in body mass index (BMI). (time frame: After 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07423884, which also lists 2 linked publications.
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 13 Apr 2026.