Pre DiabeticNCT07408791
Effects of Intermittent Fasting Variations on Metabolic, Inflammatory, and Nutrigenomic Profiles in Prediabetes: A Randomized Controlled Trial
A study testing Diet in people with Pre Diabetic, run by DINA KEUMALA SARI at 1 site in Indonesia.
Trial summary
Prediabetes is a metabolic condition associated with increased risk of type 2 diabetes and cardiovascular disease. Intermittent fasting (IF) has emerged as a potential dietary intervention to improve metabolic health, yet comparative evidence among different IF patterns remains limited. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pre Diabetic
- What is being tested?
- Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- Feb 2026to 30 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with prediabetes, defined according to ADA criteria (fasting plasma glucose 100-125 mg/dL or 2-hour postprandial glucose 140-199 mg/dL).
- Willing to follow the fasting/diet intervention protocol for 4-6 weeks (depending on the study duration).
- Signing informed consent and willing to be randomized into one of 3 intervention groups (Monday-Thursday Fasting/5:2, Alternate-Day Fasting/ADF, or Time-Restricted Fasting/IF).
Who cannot join
- Diagnosis of type 2 diabetes mellitus.
- Currently undergoing antidiabetic drug therapy (e.g., metformin, sulfonylurea, insulin).
- Has a severe chronic disease (kidney failure, liver failure, heart failure, or eating disorder).
- Pregnancy or breastfeeding.
- History of eating disorders (anorexia nervosa, bulimia nervosa, or binge eating disorder).
- Taking medications that affect glucose metabolism (e.g., systemic steroids, atypical antipsychotics, etc.). Diagnosis of type 2 diabetes
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
Department of Internal Medicine - Endocrinology Division, Faculty of Medicine, Universitas Sumatera Utara / RSUP H. Adam Malik Medan
Medan, North Sumatera
Muhammad Aron Pase, MD, +6285360148731, aronpase@usu.ac.id
About this study
Official title: The Effect of Intermittent Fasting Variations on Nutrigenomic Profile, Changes in Metabolic and Inflammatory Parameters, and Body Composition in Patients With Prediabetes
Prediabetes is a metabolic condition associated with increased risk of type 2 diabetes and cardiovascular disease. Intermittent fasting (IF) has emerged as a potential dietary intervention to improve metabolic health, yet comparative evidence among different IF patterns remains limited.
This randomized controlled trial aims to evaluate the effects of three intermittent fasting regimens-5:2 fasting, alternate-day fasting, and time-restricted feeding-compared with a control diet on metabolic parameters, inflammatory markers, body composition, and nutrigenomic profiles in adults with prediabetes.
- Conditions
- Pre Diabetic
- Being tested
- Diet
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
Intermittent Fasting
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting (16:8) | Experimental | Not described Receives: Behavioral: Diet |
| 5:2 Diet | Active comparator | Not described Receives: Behavioral: Diet |
| Non Fasting | No intervention | Not described |
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, Week 3, and Week 6
Secondary outcomes (4)
Lipid Profile
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
Measured: Baseline and Week 6
Nutrigenomics
Distribution of FTO gene polymorphism
Measured: Baseline
Body Composition
Change in BMI and waist circumference
Measured: Baseline, Week 3, and Week 6
Inflammation Profile
Change in inflammatory marker (CRP)
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabeticStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
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
- NCT07408791
- Sponsor's protocol ID
- USumateraUtara Metabolic
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 Feb 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Fasting Variations on Nutrigenomic Profile, Changes in Metabolic and Inflammatory Parameters, and Body Composition in Patients With Prediabetes
- ClinicalTrials.gov ID
- NCT07408791
- Acronym / sponsor ID
- USumateraUtara Metabolic
- Conditions
- Pre Diabetic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- DINA KEUMALA SARIUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 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.
Prediabetes is a metabolic condition associated with increased risk of type 2 diabetes and cardiovascular disease. Intermittent fasting (IF) has emerged as a potential dietary intervention to improve metabolic health, yet comparative evidence among different IF patterns remains limited.
This randomized controlled trial aims to evaluate the effects of three intermittent fasting regimens-5:2 fasting, alternate-day fasting, and time-restricted feeding-compared with a control diet on metabolic parameters, inflammatory markers, body composition, and nutrigenomic profiles in adults with prediabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting (16:8) | Experimental | Behavioral: Diet |
| 5:2 Diet | Active comparator | Behavioral: Diet |
| Non Fasting | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with prediabetes, defined according to ADA criteria (fasting plasma glucose 100-125 mg/dL or 2-hour postprandial glucose 140-199 mg/dL).
- Willing to follow the fasting/diet intervention protocol for 4-6 weeks (depending on the study duration).
- Signing informed consent and willing to be randomized into one of 3 intervention groups (Monday-Thursday Fasting/5:2, Alternate-Day Fasting/ADF, or Time-Restricted Fasting/IF).
Key exclusion criteria (6 listed)
- Diagnosis of type 2 diabetes mellitus.
- Currently undergoing antidiabetic drug therapy (e.g., metformin, sulfonylurea, insulin).
- Has a severe chronic disease (kidney failure, liver failure, heart failure, or eating disorder).
- Pregnancy or breastfeeding.
- History of eating disorders (anorexia nervosa, bulimia nervosa, or binge eating disorder).
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 |
|---|---|---|
| DietIntermittent Fasting | Behavioural | 5:2 Diet, Intermittent Fasting (16:8) |
Primary outcome
Metabolic Profile
Time frame: Baseline, Week 3, and Week 6
Change in Fasting Plasma Glucose (mg/dL)
4 secondary outcomes
Lipid Profile
Time frame: Baseline and Week 6
Nutrigenomics
Time frame: Baseline
Body Composition
Time frame: Baseline, Week 3, and Week 6
Inflammation Profile
Time frame: Baseline and Week 6
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 Feb 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.
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 in people with Pre Diabetic, 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 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 Feb 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 Muhammad Aron Pase, MD (+6285360148731, aronpase@usu.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Profile (time frame: Baseline, Week 3, and Week 6). 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 13 Feb 2026.