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Not yet recruitingNCT07408791Updated Feb 13, 2026

Effects of Intermittent Fasting Variations on Metabolic, Inflammatory, and Nutrigenomic Profiles in Prediabetes: A Randomized Controlled Trial

An interventional study of Diet in Pre Diabetic, sponsored by DINA KEUMALA SARI. Not yet recruiting at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by DINA KEUMALA SARI · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
01

Study 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.

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.

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Conditions studied

  • Pre Diabetic

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03

In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

DINA KEUMALA SARI is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with prediabetes, defined according to ADA criteria (fasting plasma glucose 100-125 mg/dL or 2-hour postprandial glucose 140-199 mg/dL).
  2. Willing to follow the fasting/diet intervention protocol for 4-6 weeks (depending on the study duration).
  3. 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).

Exclusion criteria

Exclusion Criteria

  1. Diagnosis of type 2 diabetes mellitus.
  2. Currently undergoing antidiabetic drug therapy (e.g., metformin, sulfonylurea, insulin).
  3. Has a severe chronic disease (kidney failure, liver failure, heart failure, or eating disorder).
  4. Pregnancy or breastfeeding.
  5. History of eating disorders (anorexia nervosa, bulimia nervosa, or binge eating disorder).
  6. Taking medications that affect glucose metabolism (e.g., systemic steroids, atypical antipsychotics, etc.). Diagnosis of type 2 diabetes
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Intermittent Fasting (16:8)

    Behavioral: Diet

  • Active comparator
    5:2 Diet

    Behavioral: Diet

  • No intervention
    Non Fasting

Interventions

  • BehavioralDiet

    Intermittent Fasting

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What researchers measure

Primary outcomes

  1. Metabolic Profile

    Change in Fasting Plasma Glucose (mg/dL)

    Time frame: Baseline, Week 3, and Week 6

Secondary outcomes

  1. Lipid Profile

    Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)

    Time frame: Baseline and Week 6

  2. Nutrigenomics

    Distribution of FTO gene polymorphism

    Time frame: Baseline

  3. Body Composition

    Change in BMI and waist circumference

    Time frame: Baseline, Week 3, and Week 6

  4. Inflammation Profile

    Change in inflammatory marker (CRP)

    Time frame: Baseline and Week 6

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Study locations

1 site
  • Department of Internal Medicine - Endocrinology Division, Faculty of Medicine, Universitas Sumatera Utara / RSUP H. Adam Malik Medan
    Medan, North Sumatera, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07408791
Lead sponsor
DINA KEUMALA SARI
Responsible party
DINA KEUMALA SARI (Prof, Universitas Sumatera Utara) — Sponsor-investigator
First posted
Feb 13, 2026
Start date
Feb 2026 (estimated)
Primary completion
May 31, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Feb 13, 2026

Study contacts

Muhammad Aron Pase, MD
Contact
aronpase@usu.ac.id
+6285360148731

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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