Effects of Intermittent Fasting Variations on Nutrigenomic Profile, Metabolic Parameters, Inflammation, and Body Composition in Prediabetic Patients

NCT07755982 | Not Yet Recruiting DMC

• 1 other identifier: USumateraUtara Prediabetic
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre Diabetic

Outcome Measures

Primary Outcomes (1)

• Metabolic Profile

  Change in Fasting Plasma Glucose (mg/dL)

  Baseline, Week 3, and Week 6

Secondary Outcomes (8)

• Lipid Profile

  Baseline and Week 6

• Lipid Profile

  Baseline and Week 6

• Lipid Profile

  Baseline and Week 6

• Lipid Profile

  Baseline and Week 6

• Nutrigenomics

  Baseline

Study Arms (3)

Intermittent Fasting (16:8)

EXPERIMENTAL

Behavioral: Diet

5:2 Diet

ACTIVE COMPARATOR

Behavioral: Diet

Non Fasting

NO INTERVENTION

Interventions

Diet BEHAVIORAL

Intermittent Fasting

5:2 Diet; Intermittent Fasting (16:8)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aron Pase: lead

Study Sites (1)

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

Medan, North Sumatera, Indonesia

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Diet

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Muhammad Aron Pase, MD

CONTACT

+6285360148731; aronpase@usu.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Clinical Physicians in Endocrinology

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2026-2030
• Access Criteria: email

Locations

ID (1)