Diet InterventionsNCT07800884
Correlation Between Dietary Patterns, Anthropometric Profiles, Genetic Profiles, and Biomarker Levels to Diabetes
A study testing diet intervention in people with Diet Interventions and Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to explore the correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in diabetes in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Interventions, Diabetes Mellitus
- What is being tested?
- diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Apr 2025to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-59 years
- Participants must provide informed consent to participate in the study, which include dietary tracking, biometric testing, and adherence to the intervention program.
- Participants must be available for the full duration of the study (one months) and able to comply with the scheduled meal plans and testing appointments.
Who cannot join
- Individuals with history of type 1 and 2 diabetes, autoimmune, thyroid disease, which may affect carbohydrate metabolism.
- Individuals who have experienced major surgery in the past six months, as it might impact carbohydrate metabolism and the body's reaction to dietary modifications.
- Individuals with eating disorders, given the potential risks associated with dietary changes and the focus on food intake and biometrics.
- Individuals with allergies or intolerances to the ingredients used in the study's meal plans to prevent adverse health effects and ensure participant safety.
- Individuals currently participating in other clinical trials that could influence the outcomes of this study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Universitas Trisakti
Jakarta, DKI Jakarta, 11440
About this study
Official title: Elucidating the Correlation Between Dietary Patterns, Anthropometric Measurements, Genetic Profiles, and Biomarker Levels Related to Diabetes
The goal of this clinical trial is to explore the correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in diabetes in healthy adults.
The primary objective is to examine the correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in the context of diabetes.
Read more
Secondary Objectives:
- To examine the relationship between the diabetes parameters, dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels in the intervention group and control group following a month-long diet.
- To examine the correlation between subjects' characteristics (age, sex, educational background, ethnic background, and economic status) and diabetes parameters
- To examine the correlation between subjects' life habits (exercise, smoking, sleeping) and diabetes parameters
- To examine the compliance of subjects to study intervention
- To examine the progression of anthropometric measurements during the study period
- The process involves identifying changes between markers related to the development of diabetes.
- To develop a risk prediction of diabetes based on dietary intake and health indicators.
Hypothesis: There was a correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in the context of diabetes.
Participants: One hundred fifty individuals will participate in the study, providing substantial data for analysis. Participants will undergo dietary interventions and biomarker testing (continuous and checkpoint) to establish baseline data for health indicators, specifically diabetes. Three groups of participants will be recruited:
- Case group: Balanced healthy diet group, eating 45-65% of calories from carbohydrates, 20-25% of calories from fat, and 10% from protein.
- Low-carb diet group: an eating pattern with <45% of total energy provided by carbohydrates. This group will undergo two different meal diets to see changes in blood biomarkers due to specific diet variations.
- Control group: this group will not receive a diet intervention.
Read the detailed description
Subject recruitment starts by sharing information across various platforms, such as WhatsApp groups and brochures distributed on the Trisakti University campus. Recruitment is open to students, faculty members, their families, and residents living near Trisakti University. Subsequently, an online meeting is held to outline the participation requirements, research stages, timeline, potential benefits, and possible side effects. A Google Form is then distributed for completion by meeting attendees who are genuinely interested in participating. Concurrently with subject recruitment, the eligibility of the catering service responsible for preparing the meals-specifically for the balanced diet and low-carb diet groups-is assessed.
The dietary regimen covers three main meals and two snacks daily. Meals are delivered three times a day: the first and second deliveries (covering breakfast, lunch, and morning/afternoon snacks) are made to the Trisakti University campus, while the third delivery is made directly to each subject's home. Deliveries take place on weekdays (Monday through Friday), with no deliveries on Saturdays or Sundays. A dietitian monitors dietary intake two to three times per week. Before the study begins, dietary education on balanced nutrition is provided to the balanced diet and control groups; the low-carb group also receives specific dietary education. This education ensures that subjects can maintain their prescribed diets on Saturdays and Sundays when no meals are delivered.
At the beginning of the study, all participants underwent fasting blood glucose testing to exclude those with fasting blood glucose levels >100 mg/dL. Subsequently, baseline laboratory tests were performed, and the experimental study commenced. The study was conducted over four weeks. Caloric intake is determined on an individual basis. A dietitian records and documents meal delivery daily.
At the conclusion of the study, a meeting will be held featuring a geneticist to explain the genetic test results, an internist to interpret the laboratory findings, and a nutrition specialist to provide dietary guidance based on the study results, followed by a health discussion related to the research topic.
- Conditions
- Diet Interventions, Diabetes Mellitus
- Being tested
- diet intervention
- Keywords
- diet, diabetes mellitus, genetic, biomarker
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet interventionOther
Subjects in the treatment group will be given a balanced diet or low-carb diet based on the amount of carbohydrates given.
| Study group | Role | What they receive |
|---|---|---|
| balanced, healthy diet | Experimental | Balanced healthy diet group, eating 45 - 65% of calories from carbohydrates, 20 - 25% of calories from fat, and 10% from protein Receives: Other: diet intervention |
| a low-carbohydrate diet group | Experimental | Low-carb diet group, eating pattern with less than 45% of total energy provided by carbohydrates. Receives: Other: diet intervention |
| Control group | No intervention | Subjects in the control group did not receive a special diet, only their dietary intake was monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
will be presented as a percentage.
Measured: at enrollment and at the end of treatment in week 4
Fasting glucose
will be presented in mg/dL
Measured: at enrollment and at the end of treatment in week 4
Fasting insulin
will be presented in μU/mL
Measured: at enrollment and at the end of treatment in week 4
Secondary outcomes (9)
Body weight
will be measured in kg
Measured: at enrollment and at the end of treatment in week 4
Body mass index
is expressed in kg/m^2
Measured: at enrollment and at the end of treatment in week 4
Cholesterol
is expressed in mg/dL
Measured: at enrollment and at the end of treatment in week 4
Low density cholesterol (LDL)
is expressed in mg/dL
Measured: at enrollment and at the end of treatment in week 4
High density cholesterol (HDL)
is expressed in mg/dL
Measured: at enrollment and at the end of treatment in week 4
Trigliserida
is expressed in mg/dL
Measured: at enrollment and at the end of treatment in week 4
Alanine Aminotransferase
is expressed in U/L
Measured: at enrollment and at the end of treatment in week 4
Aspartate Aminotransferase
is expressed in U/L
Measured: at enrollment and at the end of treatment in week 4
Total bilirubin
is expressed in mg/dL
Measured: at enrollment and at the end of treatment in week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start28 Apr 2025
- Primary completion16 Jul 2025
- Study completion2 Sep 2025
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 Diet InterventionsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verawati Sudarma, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800884
- Sponsor's protocol ID
- 013/KER/FK/04/2025
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not or may not be shared to maintain the confidentiality of subject data.
Publications
Yu EY, Ren Z, Mehrkanoon S, Stehouwer CDA, van Greevenbroek MMJ, Eussen SJPM, Zeegers MP, Wesselius A. Plasma metabolomic profiling of dietary patterns associated with glucose metabolism status: The Maastricht Study. BMC Med. 2022 Nov 21;20(1):450. doi: 10.1186/s12916-022-02653-1.
PubMed 36414942Esmaillzadeh A, Kimiagar M, Mehrabi Y, Azadbakht L, Hu FB, Willett WC. Dietary patterns, insulin resistance, and prevalence of the metabolic syndrome in women. Am J Clin Nutr. 2007 Mar;85(3):910-8. doi: 10.1093/ajcn/85.3.910.
PubMed 17344515
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Correlation Between Dietary Patterns, Anthropometric Measurements, Genetic Profiles, and Biomarker Levels Related to Diabetes
- ClinicalTrials.gov ID
- NCT07800884
- Acronym / sponsor ID
- 013/KER/FK/04/2025
- Conditions
- Diet Interventions, Diabetes Mellitus
- Keywords
- diet, diabetes mellitus, genetic, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 2 Sep 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.
The goal of this clinical trial is to explore the correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in diabetes in healthy adults.
The primary objective is to examine the correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in the context of diabetes.
Secondary Objectives:
- To examine the relationship between the diabetes parameters, dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels in the intervention group and control group following a month-long diet.
- To examine the correlation between subjects' characteristics (age, sex, educational background, ethnic background, and economic status) and diabetes parameters
- To examine the correlation between subjects' life habits (exercise, smoking, sleeping) and diabetes parameters
- To examine the compliance of subjects to study intervention
- To examine the progression of anthropometric measurements during the study period
- The process involves identifying changes between markers related to the development of diabetes.
- To develop a risk prediction of diabetes based on dietary intake and health indicators.
Hypothesis: There was a correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in the context of diabetes.
Participants: One hundred fifty individuals will participate in the study, providing substantial data for analysis. Participants will undergo dietary interventions and biomarker testing (continuous and checkpoint) to establish baseline data for health indicators, specifically diabetes. Three groups of participants will be recruited:
- Case group: Balanced healthy diet group, eating 45-65% of calories from carbohydrates, 20-25% of calories from fat, and 10% from protein.
- Low-carb diet group: an eating pattern with <45% of total energy provided by carbohydrates. This group will undergo two different meal diets to see changes in blood biomarkers due to specific diet variations.
- Control group: this group will not receive a diet intervention.
Detailed description
Subject recruitment starts by sharing information across various platforms, such as WhatsApp groups and brochures distributed on the Trisakti University campus. Recruitment is open to students, faculty members, their families, and residents living near Trisakti University. Subsequently, an online meeting is held to outline the participation requirements, research stages, timeline, potential benefits, and possible side effects. A Google Form is then distributed for completion by meeting attendees who are genuinely interested in participating. Concurrently with subject recruitment, the eligibility of the catering service responsible for preparing the meals-specifically for the balanced diet and low-carb diet groups-is assessed.
The dietary regimen covers three main meals and two snacks daily. Meals are delivered three times a day: the first and second deliveries (covering breakfast, lunch, and morning/afternoon snacks) are made to the Trisakti University campus, while the third delivery is made directly to each subject's home. Deliveries take place on weekdays (Monday through Friday), with no deliveries on Saturdays or Sundays. A dietitian monitors dietary intake two to three times per week. Before the study begins, dietary education on balanced nutrition is provided to the balanced diet and control groups; the low-carb group also receives specific dietary education. This education ensures that subjects can maintain their prescribed diets on Saturdays and Sundays when no meals are delivered.
At the beginning of the study, all participants underwent fasting blood glucose testing to exclude those with fasting blood glucose levels >100 mg/dL. Subsequently, baseline laboratory tests were performed, and the experimental study commenced. The study was conducted over four weeks. Caloric intake is determined on an individual basis. A dietitian records and documents meal delivery daily.
At the conclusion of the study, a meeting will be held featuring a geneticist to explain the genetic test results, an internist to interpret the laboratory findings, and a nutrition specialist to provide dietary guidance based on the study results, followed by a health discussion related to the research topic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| balanced, healthy diet | Experimental | Other: diet interventionBalanced healthy diet group, eating 45 - 65% of calories from carbohydrates, 20 - 25% of calories from fat, and 10% from protein |
| a low-carbohydrate diet group | Experimental | Other: diet interventionLow-carb diet group, eating pattern with less than 45% of total energy provided by carbohydrates. |
| Control group | No intervention | –Subjects in the control group did not receive a special diet, only their dietary intake was monitored. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-59 years
- Participants must provide informed consent to participate in the study, which include dietary tracking, biometric testing, and adherence to the intervention program.
- Participants must be available for the full duration of the study (one months) and able to comply with the scheduled meal plans and testing appointments.
Key exclusion criteria (5 listed)
- Individuals with history of type 1 and 2 diabetes, autoimmune, thyroid disease, which may affect carbohydrate metabolism.
- Individuals who have experienced major surgery in the past six months, as it might impact carbohydrate metabolism and the body's reaction to dietary modifications.
- Individuals with eating disorders, given the potential risks associated with dietary changes and the focus on food intake and biometrics.
- Individuals with allergies or intolerances to the ingredients used in the study's meal plans to prevent adverse health effects and ensure participant safety.
- Individuals currently participating in other clinical trials that could influence the outcomes of this study.
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 |
|---|---|---|
| diet interventionSubjects in the treatment group will be given a balanced diet or low-carb diet based on the amount of carbohydrates given. | Other | a low-carbohydrate diet group, balanced, healthy diet |
Primary outcome
HbA1C
Time frame: at enrollment and at the end of treatment in week 4
will be presented as a percentage.
Fasting glucose
Time frame: at enrollment and at the end of treatment in week 4
will be presented in mg/dL
Fasting insulin
Time frame: at enrollment and at the end of treatment in week 4
will be presented in μU/mL
9 secondary outcomes
Body weight
Time frame: at enrollment and at the end of treatment in week 4
Body mass index
Time frame: at enrollment and at the end of treatment in week 4
Cholesterol
Time frame: at enrollment and at the end of treatment in week 4
Low density cholesterol (LDL)
Time frame: at enrollment and at the end of treatment in week 4
High density cholesterol (HDL)
Time frame: at enrollment and at the end of treatment in week 4
Trigliserida
Time frame: at enrollment and at the end of treatment in week 4
Alanine Aminotransferase
Time frame: at enrollment and at the end of treatment in week 4
Aspartate Aminotransferase
Time frame: at enrollment and at the end of treatment in week 4
Total bilirubin
Time frame: at enrollment and at the end of treatment in week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 36414942Yu EY, Ren Z, Mehrkanoon S, Stehouwer CDA, van Greevenbroek MMJ, Eussen SJPM, Zeegers MP, Wesselius A. Plasma metabolomic profiling of dietary patterns associated with glucose metabolism status: The Maastricht Study. BMC Med. 2022 Nov 21;20(1):450. doi: 10.1186/s12916-022-02653-1.
- Results publication: PubMed 17344515Esmaillzadeh A, Kimiagar M, Mehrabi Y, Azadbakht L, Hu FB, Willett WC. Dietary patterns, insulin resistance, and prevalence of the metabolic syndrome in women. Am J Clin Nutr. 2007 Mar;85(3):910-8. doi: 10.1093/ajcn/85.3.910.
- Individual participant dataSharing planned: No. IPD will not or may not be shared to maintain the confidentiality of subject data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet intervention in people with Diet Interventions and Diabetes Mellitus, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1C (time frame: at enrollment and at the end of treatment in week 4). The study lists 3 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 NCT07800884, 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 2 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.