ClinicalTrials.gg
Not yet recruitingNCT07755982Updated Aug 10, 2026

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

An interventional study of Diet in Pre Diabetic, sponsored by Muhammad Aron Pase. Not yet recruiting at 1 site in Indonesia. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Muhammad Aron Pase · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study 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.

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Conditions studied

  • Pre Diabetic

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03

In context

Glucose Intolerance

793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.

This study's planned enrollment of 120 is above the median of 56 across 661 interventional studies indexed under Glucose Intolerance.

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Lead sponsor

This is the only study on the registry with Muhammad Aron Pase as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with prediabetes, defined according to ADA criteria (fasting plasma glucose 100-125 mg/dL or 2-hour postprandial glucose 140-199 mg/dL).
  2. Willing to follow the fasting/diet intervention protocol for 4-6 weeks (depending on the study duration).
  3. Signing 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

Exclusion Criteria

  1. Diagnosis of type 2 diabetes mellitus.
  2. Currently undergoing antidiabetic drug therapy (e.g., metformin, sulfonylurea, insulin).
  3. Has a severe chronic disease (kidney failure, liver failure, heart failure, or eating disorder).
  4. Pregnancy or breastfeeding.
  5. History of eating disorders (anorexia nervosa, bulimia nervosa, or binge eating disorder).
  6. Taking medications that affect glucose metabolism (e.g., systemic , atypical antipsychotics, etc.). Diagnosis of type 2 diabetes
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Intermittent Fasting (16:8)

    Behavioral: Diet

  • Active comparator
    5:2 Diet

    Behavioral: Diet

  • No intervention
    Non Fasting

Interventions

  • BehavioralDiet

    Intermittent Fasting

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What researchers measure

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

  5. Nutrigenomics

    Distribution of Fat Mass and Obesity-Associated gene polymorphism with Enzyme-Linked Immunosorbent Assay method

    Time frame: Baseline

  6. Body Composition

    Change in BMI

    Time frame: Baseline, Week 3, and Week 6

  7. Body Composition

    Change in Waist Circumference

    Time frame: Baseline, Week 3, and Week 6

  8. Inflammation Profile

    Concentration Changes of inflammatory marker (CRP)

    Time frame: Baseline and Week 6

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Study locations

1 site
  • Department of Internal Medicine - Endocrinology Division, Faculty of Medicine, Universitas Sumatera Utara / RSUP H. Adam Malik Medan
    Medan, North Sumatera, Indonesia
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References and documents

Individual participant data

Plan to share: Yes — only IPD used in the results publication

Supporting information: Study protocol, Clinical study report

Time frame: 2026-2030

Access criteria: email

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07755982
Lead sponsor
Muhammad Aron Pase
Responsible party
Muhammad Aron Pase (MD, Clinical Physicians in Endocrinology, Universitas Sumatera Utara) — Sponsor-investigator
First posted
Aug 10, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Aug 10, 2026

Study contacts

Muhammad Aron Pase, MD
Contact
aronpase@usu.ac.id
+6285360148731

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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