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

ConditionPre Diabetic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorMuhammad Aron Pase

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diet

    Behavioral

    Intermittent Fasting

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Intermittent Fasting (16:8)Experimental treatment 1 intervention
Group B: 5:2 DietActive comparator 1 intervention
Group C: Non FastingNo intervention 0 interventions

Trial outcomes

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

Concentration Changes of Total Cholesterol

Time frame
Baseline and Week 6
2

Lipid Profile

Concentration Changes of LDL

Time frame
Baseline and Week 6
3

Lipid Profile

Concentration Changes of HDL

Time frame
Baseline and Week 6
4

Lipid Profile

Concentration Changes of Triglycerides

Time frame
Baseline and Week 6

Other outcomes

Sponsors and contacts

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Muhammad Aron Pase

Lead sponsor

Universitas Sumatera Utara

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: