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Not yet recruiting NCT07408791

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

No phase Interventional Pre Diabetic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet.
Who it may be relevant to
Registry conditions: Pre Diabetic. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Diet
    Intermittent Fasting

Primary outcome measures

  • Metabolic Profile [Time frame: Baseline, Week 3, and Week 6]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Indonesia · 1 center
  • Department of Internal Medicine - Endocrinology Division, Faculty of Medicine, Universitas — Medan

Identifiers

NCT: NCT07408791 · USumateraUtara Metabolic

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗