Type 2 DiabetesNCT07696013
The Effect of Personalized Nutrition on Changes in Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
A study testing Personalized Nutrition and Generalized Nutrition in people with Type 2 Diabetes, run by DINA KEUMALA SARI at 1 site in Indonesia.
Trial summary
Type 2 diabetes mellitus (T2DM) is a multifactorial metabolic disorder commonly accompanied by obesity, hypertension, and suboptimal glycemic control, which together increase cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Personalized Nutrition and Generalized Nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2025to 31 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged >18 years
- A confirmed diagnosis of type 2 diabetes mellitus based on the Fasting Blood Glucose more than 126 mg/dL
- Willingness to participate in dietary counseling sessions and undergo metabolic assessments throughout the study period
- Provision of written informed consent prior to participation
Who cannot join
- Currently following a special or therapeutic diet prescribed by a physician or dietitian
- Previous receipt of dietary counseling
- Presence of comorbid conditions known to affect metabolic function, as identified through a standardized screening questionnaire
- Use of weight-loss medications or metabolically active dietary supplements, as determined by the screening form
- Pregnancy or lactation, as assessed by medical history and physical examination
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia
Medan, North Sumatera
About this study
Type 2 diabetes mellitus (T2DM) is a multifactorial metabolic disorder commonly accompanied by obesity, hypertension, and suboptimal glycemic control, which together increase cardiovascular risk. Conventional dietary recommendations often apply a uniform approach and may not adequately address interindividual metabolic variability. Personalized nutrition has therefore gained attention as a strategy to optimize metabolic outcomes through individualized dietary interventions. This controlled intervention study evaluated the effect of a personalized nutrition program "my plate" on metabolic parameters in patients with T2DM. Participants were assigned to either an intervention group receiving personalized dietary guidance or a control group receiving standard care. Anthropometric parameters (body weight, body mass index, and waist circumference), fasting plasma glucose, and blood pressure were assessed at baseline and after the intervention
- Conditions
- Type 2 Diabetes
- Being tested
- Personalized Nutrition, Generalized Nutrition
- Keywords
- Blood pressure; Glycemic control; Metabolic health; Obesity; Personalized nutrition; Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized NutritionOther
Personalized nutrition based on individual calorie calculation is an approach that adjusts a person's energy intake and macronutrient composition according to their estimated caloric needs derived from age, sex, body weight, height, and physical activity level.
Generalized NutritionOther
Generalized Nutrition means giving the dietary counseling that recommended by health ministry of Indonesia
| Study group | Role | What they receive |
|---|---|---|
| Personalized Nutrition | Experimental | Intervention Group Receives: Other: Personalized Nutrition |
| Generalized Nutrition | Sham comparator | Control Group Receives: Other: Generalized Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Profile
Change in Fasting Plasma Glucose (mg/dL)
Measured: Baseline, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- DINA KEUMALA SARI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DINA KEUMALA SARI, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696013
- Sponsor's protocol ID
- USumateraUtara
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Personalized Nutrition on Changes in Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07696013
- Acronym / sponsor ID
- USumateraUtara
- Conditions
- Type 2 Diabetes
- Keywords
- Blood pressure; Glycemic control; Metabolic health; Obesity; Personalized nutrition; Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DINA KEUMALA SARIUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 10 Jul 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.
Type 2 diabetes mellitus (T2DM) is a multifactorial metabolic disorder commonly accompanied by obesity, hypertension, and suboptimal glycemic control, which together increase cardiovascular risk. Conventional dietary recommendations often apply a uniform approach and may not adequately address interindividual metabolic variability. Personalized nutrition has therefore gained attention as a strategy to optimize metabolic outcomes through individualized dietary interventions. This controlled intervention study evaluated the effect of a personalized nutrition program "my plate" on metabolic parameters in patients with T2DM. Participants were assigned to either an intervention group receiving personalized dietary guidance or a control group receiving standard care. Anthropometric parameters (body weight, body mass index, and waist circumference), fasting plasma glucose, and blood pressure were assessed at baseline and after the intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Nutrition | Experimental | Other: Personalized NutritionIntervention Group |
| Generalized Nutrition | Sham comparator | Other: Generalized NutritionControl Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants aged >18 years
- A confirmed diagnosis of type 2 diabetes mellitus based on the Fasting Blood Glucose more than 126 mg/dL
- Willingness to participate in dietary counseling sessions and undergo metabolic assessments throughout the study period
- Provision of written informed consent prior to participation
Key exclusion criteria (5 listed)
- Currently following a special or therapeutic diet prescribed by a physician or dietitian
- Previous receipt of dietary counseling
- Presence of comorbid conditions known to affect metabolic function, as identified through a standardized screening questionnaire
- Use of weight-loss medications or metabolically active dietary supplements, as determined by the screening form
- Pregnancy or lactation, as assessed by medical history and physical examination
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 |
|---|---|---|
| Personalized NutritionPersonalized nutrition based on individual calorie calculation is an approach that adjusts a person's energy intake and macronutrient composition according to their estimated caloric needs derived from age, sex, body weight, height, and physical activity level. | Other | Personalized Nutrition |
| Generalized NutritionGeneralized Nutrition means giving the dietary counseling that recommended by health ministry of Indonesia | Other | Generalized Nutrition |
Primary outcome
Metabolic Profile
Time frame: Baseline, and 12 weeks
Change in Fasting Plasma Glucose (mg/dL)
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 10 Jul 2026.
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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 Personalized Nutrition and Generalized Nutrition in people with Type 2 Diabetes, run by DINA KEUMALA SARI 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 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 10 Jul 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. Some participants in this study may receive a placebo. 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?
Metabolic Profile (time frame: Baseline, and 12 weeks). 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 Jul 2026.