Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding

ConditionsMitochondrial Degradation Autophagy Fasting Healthy Volunteers Metabolic Adaptation

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-50

SponsorBahcesehir Cyprus University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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]

Disqualifiers

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]

Trial population

The study population consists of healthy adult volunteers aged 18 to 50 with a BMI between 18.5 and 30.0 kg/m². The cohort represents individuals who are either observing the religious dry fast of Ramadan or concurrently practicing standard 16:8 time-restricted feeding. Participants are recruited from the academic and local communities of Bahçeşehir Cyprus University and Near East University in Nicosia, Northern Cyprus\[cite: 1\]. The sample includes both males and females who do not smoke, have stable sleep-wake cycles, and are free from chronic diseases requiring regular prescription medications\[cite: 1\].

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Ramadan Intermittent Dry Fasting (Sawm)
Behavioral
Total fluid and nutrient restriction enforced daily from dawn (Fajr) to sunset (Maghrib) for 30 consecutive days. Food and fluid consumption are restricted to the nocturnal period
16:8 Time-Restricted Feeding (TRF)
Behavioral
A 16-hour daily fasting window where calorie-containing foods and beverages are completely restricted. Fluid intake (such as water or uncaloried drinks) is permitted throughout the fasting period

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Arm A: Ramadan Dry Fasting1 intervention

Group B: Arm B: 16:8 Time-Restricted Feeding1 intervention

Trial outcomes

Primary outcomes

Between-arm difference in PINK1 and Parkin mitophagy gene expression

Relative expression levels of PINK1 and Parkin mRNA will be quantified via probe-based quantitative reverse transcription PCR (qRT-PCR) from isolated peripheral blood mononuclear cells (PBMCs). Normalization will be performed using the geometric mean of housekeeping genes GAPDH and B2M. Evaluation will focus on the between-arm contrast (Arm A vs. Arm B) of the change metric using relative quantification (2\^-ΔΔCt).

Time frame

Change from baseline (Day -3) to Day 30 of the fasting period

Between-arm difference in mitochondrial DNA copy number (mtCN)

Mitochondrial DNA copy number will be quantified by qPCR targeting the mitochondrial reference region MT-RNR1 (12S rRNA), normalized to the nuclear reference gene B2M. Relative mtCN is calculated using the formula: 2 × (Ct\_nuclear - Ct\_mtDNA). The primary evaluation is the between-arm difference in net change at Day 30 to test for a predicted U-shaped cellular trajectory

Time frame

Change from baseline (Day -3) to Day 30 of the fasting period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bahcesehir Cyprus University

Lead sponsor

Source ClinicalTrials.gov

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