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

Indonesia120 participantsStarted 2026-02

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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

What they're measuring

Metabolic Profile

Timeframe: Baseline, Week 3, and Week 6

Trial details

NCT IDNCT07408791

SponsorDINA KEUMALA SARI

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

Contact for this trial

Muhammad Aron Pase, MD

+6285360148731 aronpase@usu.ac.id

View on ClinicalTrials.gov More Pre Diabetic trials