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NCT Number: NCT07408791

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

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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Key information

Conditions

Pre Diabetic Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine - Endocrinology Division, Faculty of Medicine, Universitas Sumatera Utara / RSUP H. Adam Malik Medan

Medan, North Sumatera, Indonesia

Location contact

Muhammad Aron Pase, MD

CONTACT

[email protected]

+6285360148731

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

Intermittent Fasting

Primary outcomes

  1. Metabolic Profile

    Time frame: Baseline, Week 3, and Week 6

    Change in Fasting Plasma Glucose (mg/dL)

Secondary outcomes

  1. Lipid Profile

    Time frame: Baseline and Week 6

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

  2. Nutrigenomics

    Time frame: Baseline

    Distribution of FTO gene polymorphism

  3. Body Composition

    Time frame: Baseline, Week 3, and Week 6

    Change in BMI and waist circumference

  4. Inflammation Profile

    Time frame: Baseline and Week 6

    Change in inflammatory marker (CRP)

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Aron Pase, MD

CONTACT

[email protected]

+6285360148731

Sponsors and collaborators

Lead sponsor

DINA KEUMALA SARI

Other

Registry information

Official study title

The Effect of Intermittent Fasting Variations on Nutrigenomic Profile, Changes in Metabolic and Inflammatory Parameters, and Body Composition in Patients With Prediabetes

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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