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Not yet recruitingNCT07638696MITO FASTUpdated Jun 11, 2026

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

An observational study in Mitochondrial Degradation, Autophagy and Fasting, sponsored by Bahcesehir Cyprus University. Not yet recruiting at 1 site in Cyprus. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Primary conditionIntermittent FastingRegistry: FastingReclassifiedWhy we changed it
Registry
Fasting — the first condition term the registry derived for this study.
ClinicalTrials.gg
Intermittent Fasting
Why
  1. The study's title name Intermittent Fasting, a narrower term within Fasting.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Bahcesehir Cyprus University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

This is a prospective, single-centre, parallel-group, longitudinal observational cohort study conducted across Ramadan 2027. The study aims to evaluate the distinct molecular and metabolic trajectories of intermittent dry fasting compared to standard fluid-permitted time-restricted feeding (TRF).

Participants will be allocated to one of two parallel groups based on their self-selected, established fasting practices:

  • Group A (Ramadan Dry Fasting): Observing complete fluid and nutrient deprivation from dawn (Fajr) to sunset (Maghrib) for 30 consecutive days.
  • Group B (16:8 TRF): Practicing a 16-hour daily fasting window with water/fluids permitted, observed concurrently during the same calendar period.

Participants in both groups will be pairwise-matched based on age and BMI at screening. Blood samples will be collected from all participants at five distinct milestones:

  • T0: Pre-Ramadan baseline (Day -3)
  • T1: Acute induction phase (Day 7)
  • T2: Mitochondrial turnover phase (Day 14)
  • T3: Saturation plateau / primary endpoint (Day 30)
  • T4: Post-Ramadan recovery phase (Day 44)

Peripheral blood mononuclear cells (PBMCs) and serum will be isolated from the collected blood. Laboratory analyses will measure mitochondrial DNA (mtDNA) copy number changes via qPCR, alongside a quantitative gene expression panel evaluating key regulators of mitophagy (such as PINK1 and Parkin), mitochondrial biogenesis, and general autophagy. Secondary evaluations include routine serum metabolic indicators, inflammatory markers, and dietary monitoring to evaluate the physiological pathways predicted by computational systems pharmacology.

02

Conditions studied

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

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Keywords

  • Ramadan fasting
  • Intermittent dry fasting
  • Time-restricted feeding
  • Mitochondrial DNA
  • Mitophagy
  • PBMC
  • PINK1-Parkin
03

In context

Intermittent Fasting Reclassified

333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.

This study's planned enrollment of 120 is above the median of 67 across 12 observational studies indexed under Intermittent Fasting.

Browse Intermittent Fasting studies →

Lead sponsor

Bahcesehir Cyprus University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Compared within Intermittent Fasting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fasting. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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].

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Common Criteria (Both Arms):
  • Age 18-50 years
  • 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

Exclusion Criteria:

  • Established type 1 or type 2 diabetes ( 6.5% or higher or pharmacological antidiabetic therapy)[cite: 1]
  • Severe gastrointestinal, cardiovascular, hepatic, or renal disease ( 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 in Arabic or English[cite: 1]
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralRamadan Intermittent Dry Fasting (Sawm)

    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

  • Behavioral16:8 Time-Restricted Feeding (TRF)

    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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 38848455 ↗
  • 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. PubMed 32914566 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07638696
Lead sponsor
Bahcesehir Cyprus University
Responsible party
Ibrahim Ibrahim Shuaibu, MD (Principal Investigator, Bahcesehir Cyprus University) — Principal investigator
First posted
Jun 10, 2026
Start date
Jan 15, 2027 (estimated)
Primary completion
Apr 15, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Jun 11, 2026

Study contacts

Ibrahim Ibrahim Shuaibu, MD, Msc
Contact
ibrahim.shuaibu@baucyprus.edu.tr
+905338730889
Berna Uzun
study chair · Operational Research Institute in Healthcare, Near East University, Nicosia, TRNC, Mersin 10, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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