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

NCT07638696 | Not Yet Recruiting

• 1 other identifier: Bahcesehir Cyprus University
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitochondrial Degradation; Autophagy; Fasting; Healthy Volunteers; Metabolic Adaptation

Keywords

Ramadan fasting; Intermittent dry fasting; Time-restricted feeding; Mitochondrial DNA; Mitophagy; PBMC; PINK1-Parkin

Outcome Measures

Primary Outcomes (2)

• 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).

  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

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

Study Arms (2)

Arm A: Ramadan Dry Fasting

Participants observing complete, daily fluid and nutrient deprivation from dawn (Fajr) to sunset (Maghrib) for 30 consecutive days during Ramadan 2027

Behavioral: Ramadan Intermittent Dry Fasting (Sawm)

Arm B: 16:8 Time-Restricted Feeding

Pairwise-matched control participants practicing a fluid-permitted, 16-hour daily fasting window observed concurrently during the same calendar period

Behavioral: 16:8 Time-Restricted Feeding (TRF)

Interventions

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

Arm A: Ramadan Dry Fasting

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

Arm B: 16:8 Time-Restricted Feeding

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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\[cite: 1\].

You may qualify if:

• 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\[cite: 1\]

You may not qualify if:

• 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\[cite: 1\]

Sponsors & Collaborators

• Bahcesehir Cyprus University: lead

Study Sites (1)

Near East University

Nicosia, Cyprus

Location

Related Publications (2)

• Sarkar B, Hajra A. Hydro-phosphorothiolation of Styrene and Cyclopropane with S-Hydrogen Phosphorothioates under Ambient Conditions. Org Lett. 2024 Jun 21;26(24):5141-5145. doi: 10.1021/acs.orglett.4c01586. Epub 2024 Jun 7.

  PMID: 38848455 BACKGROUND

• Dillard J, Meng X, Nelin L, Liu Y, Chen B. Nitric oxide activates AMPK by modulating PDE3A in human pulmonary artery smooth muscle cells. Physiol Rep. 2020 Sep;8(17):e14559. doi: 10.14814/phy2.14559.

  PMID: 32914566 BACKGROUND

MeSH Terms

Conditions

Fasting; Intermittent Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Berna Uzun

  Operational Research Institute in Healthcare, Near East University, Nicosia, TRNC, Mersin 10, Turkey

  STUDY CHAIR

Central Study Contacts

Ibrahim Ibrahim Shuaibu, MD, Msc

CONTACT

+905338730889; ibrahim.shuaibu@baucyprus.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CY (1)