Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding (NCT07638696) | Clinical Trial Compass
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Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding
Cyprus120 participantsStarted 2027-01-15
Plain-language summary
This study investigates how different types of fasting affect cell health, specifically focusing on how mitochondria (the energy-producing parts of cells) are cleared and renewed. While standard intermittent fasting allows water intake, Ramadan dry fasting involves total restriction of both food and fluids from dawn to sunset.
Researchers want to see if the combined effects of fluid restriction and natural daily body rhythms during Ramadan trigger a stronger cellular cleanup process (called mitophagy) compared to standard 16:8 water-permitted fasting. The study will look at how these fasting habits change blood markers related to mitochondrial DNA and metabolic health across a 30-day period. This research will help determine if dry fasting offers distinct biological benefits for cellular renewal.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Common Criteria (Both Arms):
* Age 18-50 years
* BMI 18.5-30.0 kg/m²\[cite: 1\]
* Non-smoker for at least 12 months\[cite: 1\]
* No chronic disease requiring regular prescription medication\[cite: 1\]
* Stable sleep-wake schedule (self-reported sleep midpoint deviation less than 90 minutes)\[cite: 1\]
* Willing and able to attend all five study visits at the specified times\[cite: 1\]
Arm A Specific (Ramadan Dry Fasting):
\- Documented religious commitment and intention to complete all 30 days of Ramadan 2027 fasting\[cite: 1\]
Arm B Specific (16:8 TRF Control):
* Confirmed practice of 16:8 TRF (fasting window 16 hours or more per day) throughout the study period\[cite: 1\]
* Not observing Ramadan dry fasting during the study period\[cite: 1\]
Exclusion Criteria:
* Established type 1 or type 2 diabetes (HbA1c 6.5% or higher or pharmacological antidiabetic therapy)\[cite: 1\]
* Severe gastrointestinal, cardiovascular, hepatic, or renal disease (eGFR less than 60 mL/min/1.73m²)\[cite: 1\]
* Active cancer or chemotherapy within five years\[cite: 1\]
* Use of metformin, statins, or exogenous antioxidant supplements (vitamins C, E, NAC, CoQ10) within 30 days of screening\[cite: 1\]
* Pregnancy, lactation, or planned conception during the study period\[cite: 1\]
* Participation in another clinical study within three months\[cite: 1\]
* Inability to provide written informed consent in Arabic or English\[cite: 1\]
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between-arm difference in PINK1 and Parkin mitophagy gene expression
Timeframe: Change from baseline (Day -3) to Day 30 of the fasting period
2
Between-arm difference in mitochondrial DNA copy number (mtCN)
Timeframe: Change from baseline (Day -3) to Day 30 of the fasting period