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临床试验/NCT07703865
NCT07703865已完成不适用

Effects of Monday-Thursday Sunnah Fasting on Fecal Short-Chain Fatty Acids, Fasting GLP-1, Appetite Regulation, and Body Composition in Obese Adult Males: A Quasi-Experimental Study

University of Muhammadiyah Jakarta1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Total Fecal Short-Chain Fatty Acids

研究概览

简要总结

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.

详细描述

Intermittent fasting (IF) has emerged as a strategy to favorably modulate gut microbiota and short-chain fatty acid (SCFA) production in obesity. However, most published protocols involve wet fasting (caloric restriction with ad libitum water), which is mechanistically distinct from dry fasting. Monday-Thursday Sunnah fasting, an established Islamic practice, involves complete abstention from food and water (dry fasting) for approximately 13 hours twice weekly.

This study was conducted at the Faculty of Medicine and Health, Universitas Muhammadiyah Jakarta, from October to December 2025. Eligible participants were obese adult males (BMI ≥ 25 kg/m², waist circumference > 90 cm) aged ≥ 19 years, with no recent history of antibiotic use, probiotic supplementation, or other IF practice.

Recruitment was performed sequentially: eligible participants were first assigned to the intervention group until quota was met; subsequent eligible participants were assigned to the control group. LMM was adopted as the confirmatory analysis to account for significant baseline group differences resulting from this design.

The intervention group performed Monday-Thursday dry fasting for 8 consecutive weeks (16 fasting days total). No dietary restrictions were imposed outside fasting hours. The control group maintained habitual diet and lifestyle.

Outcomes were assessed at baseline (Week 1) and endpoint (Week 8), with appetite and dietary intake also assessed at Week 4. Primary laboratory analyses (SCFA by GC-MS, GLP-1 by ELISA) were conducted at Prodia Clinical Laboratory, Indonesia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Monday-Thursday Sunnah Dry Fasting (Behavioral)

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.

结局指标

主要结局

Total Fecal Short-Chain Fatty Acids

时间窗: Baseline (Week 1) and Week 8

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

Body Mass Index (BMI)

时间窗: Baseline (Week 1) and Week 8

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

Satiety Area Under the Curve (AUC)

时间窗: Weeks 1, 4, and 8

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)

次要结局

  • Visceral Fat Level(Baseline (Week 1) and Week 8)
  • Body Fat Percentage(Baseline (Week 1) and Week 8)
  • Dietary Fiber Intake(Weeks 1, 4, and 8)
  • 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)

研究者

发起方
University of Muhammadiyah Jakarta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tirta Prawita Sari

Principal Investigator; Doctoral Candidate, Faculty of Medicine, Universitas Indonesia; Lecturer, Department of Nutrition, Faculty of Medicine and Health, Universitas Muhammadiyah Jakarta

University of Muhammadiyah Jakarta

研究点 (1)

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