NCT07703865

Brief Summary

This quasi-experimental study investigated the effects of 8 weeks of Monday-Thursday Sunnah fasting on fecal short-chain fatty acids (SCFA), fasting total GLP-1, appetite regulation (hunger and satiety area under the curve), dietary intake, and body composition in obese adult males in Indonesia. Monday-Thursday Sunnah fasting is a twice-weekly Islamic religious practice involving complete abstention from food and water (dry fasting) from dawn (approximately 04:30) to sunset (approximately 18:00), approximately 13 hours per day, practiced by millions of Indonesian Muslims. Unlike conventional intermittent fasting protocols, Sunnah fasting is motivated by religious observance, which may enhance adherence. Seventy-four obese adult males were enrolled (intervention n=38, control n=36). The intervention group performed 16 fasting days over 8 weeks without any caloric restriction outside fasting hours. Fecal SCFA were measured by GC-MS; fasting total GLP-1 by ELISA; appetite by Visual Analogue Scale (VAS); dietary intake by 24-hour recall; and body composition by bioelectrical impedance analysis. Primary analyses used linear mixed models (LMM) controlling for baseline differences arising from the sequential allocation design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Sunnah fastingintermittent fastingshort-chain fatty acidsGLP-1satietydry fastingIndonesia

Outcome Measures

Primary Outcomes (3)

  • Total Fecal Short-Chain Fatty Acids

    Total fecal SCFA concentration (acetate + propionate + butyrate + valerate) measured by gas chromatography-mass spectrometry (GC-MS)

    Baseline (Week 1) and Week 8

  • Body Mass Index (BMI)

    BMI calculated from measured body weight (kg) and height (m²)

    Baseline (Week 1) and Week 8

  • Satiety Area Under the Curve (AUC)

    Satiety assessed by Visual Analogue Scale (VAS) at four daily timepoints (08:00, 12:00, 16:00, 20:00); satiety AUC calculated using trapezoidal method (mm·hours)

    Weeks 1, 4, and 8

Secondary Outcomes (7)

  • Fasting Total GLP-1

    Baseline (Week 1) and Week 8

  • Hunger AUC

    Weeks 1, 4, and 8

  • Body Weight

    Baseline (Week 1) and Week 8

  • Waist Circumference

    Baseline (Week 1) and Week 8

  • Visceral Fat Level

    Baseline (Week 1) and Week 8

  • +2 more secondary outcomes

Study Arms (2)

Sunnah fasting

EXPERIMENTAL

Participants performed Monday-Thursday Sunnah dry fasting for 8 consecutive weeks (16 fasting days). Dry fasting entailed complete abstention from food and water from dawn (\~04:30) to sunset (\~18:00), approximately 13 hours per day. No dietary restrictions were imposed outside fasting hours.

Behavioral: Monday-Thursday Sunnah Dry Fasting

Control

NO INTERVENTION

Participants maintained their habitual diet and lifestyle without any fasting intervention for 8 weeks. Both groups were instructed not to modify physical activity or initiate new supplements during the study period.

Interventions

Twice-weekly daytime dry fasting (no food or water) from approximately 04:30 to 18:00 (\~13 hours), performed every Monday and Thursday for 8 consecutive weeks. This practice is based on Islamic religious Sunnah. No caloric restriction was imposed outside fasting hours.

Sunnah fasting

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male, age ≥ 19 years
  • BMI ≥ 25 kg/m² (Asia-Pacific obesity criteria)
  • Waist circumference \> 90 cm
  • No regular intermittent fasting practice in the prior month
  • No antibiotic use in the prior month
  • Not currently enrolled in any dietary or weight loss program
  • Muslim and willing to perform Monday-Thursday Sunnah fasting
  • Residing in DKI Jakarta and surrounding areas (Bogor, Depok, Tangerang)

You may not qualify if:

  • Diagnosed type 2 diabetes mellitus on oral antidiabetic agents, insulin, or GLP-1 receptor agonists
  • Coronary heart disease
  • Chronic kidney disease
  • Uncontrolled hypertension
  • Regular use of probiotics, prebiotics, fiber supplements, omega-3, or herbal supplements
  • Regular use of lipid-lowering agents, orlistat, appetite suppressants, or hormonal medications
  • Excessive alcohol consumption
  • Vegetarian diet
  • Active smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine and Health, Universitas Muhammadiyah Jakarta

South Tangerang, Banten, 15419, Indonesia

Location

MeSH Terms

Conditions

ObesityOverweightIntermittent Fasting

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Officials

  • Tirta P Sari, Medical Doctor

    University of Muhammadiyah Jakarta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Doctoral Candidate, Faculty of Medicine, Universitas Indonesia; Lecturer, Department of Nutrition, Faculty of Medicine and Health, Universitas Muhammadiyah Jakarta

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

September 15, 2025

Primary Completion

December 11, 2025

Study Completion

December 29, 2025

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations