Mitochondrial DegradationMITO FASTNCT07638696
Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding
An observational study of Mitochondrial Degradation and Autophagy, run by Bahcesehir Cyprus University at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Degradation, Autophagy, Fasting
- What is being tested?
- Ramadan Intermittent Dry Fasting (Sawm) and 16:8 Time-Restricted Feeding (TRF)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Jan 2027to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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].
Who may be able to join
- 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]
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- 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]
Who cannot join
- 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]
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus1 site
Near East University
Nicosia
Berna Uzun, Prof., +90 533 871 98 38, berna.uzun@neu.edu.tr
Adanze Cynthia Nge
About this study
Official title: Mitophagic Flux and Mitochondrial DNA Dynamics During Circadian-Aligned Ramadan Dry Fasting Versus 16:8 Time-Restricted Feeding: A Four-Phase Translational Research Programme
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.
- Being tested
- Ramadan Intermittent Dry Fasting (Sawm), 16:8 Time-Restricted Feeding (TRF)
- Keywords
- Ramadan fasting, Intermittent dry fasting, Time-restricted feeding, Mitochondrial DNA, Mitophagy, PBMC, PINK1-Parkin
- Medical subject headings
- Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramadan Intermittent Dry Fasting (Sawm)Behavioural
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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: 16:8 Time-Restricted Feeding (TRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Change from baseline (Day -3) to Day 30 of the fasting period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial DegradationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahcesehir Cyprus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ibrahim Shuaibu, MD, Bahcesehir Cyprus University
- Investigators
- Berna Uzun, Study chair, Operational Research Institute in Healthcare, Near East University, Nicosia, TRNC, Mersin 10, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638696
- Sponsor's protocol ID
- Bahcesehir Cyprus University
- Acronym
- MITO FAST
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 38848455Dillard 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitophagic Flux and Mitochondrial DNA Dynamics During Circadian-Aligned Ramadan Dry Fasting Versus 16:8 Time-Restricted Feeding: A Four-Phase Translational Research Programme
- ClinicalTrials.gov ID
- NCT07638696
- Acronym / sponsor ID
- MITO FAST / Bahcesehir Cyprus University
- Keywords
- Ramadan fasting, Intermittent dry fasting, Time-restricted feeding, Mitochondrial DNA, Mitophagy, PBMC, PINK1-Parkin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bahcesehir Cyprus UniversityUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ramadan Dry Fasting | – | Behavioral: Ramadan Intermittent Dry Fasting (Sawm)Participants observing complete, daily fluid and nutrient deprivation from dawn (Fajr) to sunset (Maghrib) for 30 consecutive days during Ramadan 2027 |
| Arm B: 16:8 Time-Restricted Feeding | – | Behavioral: 16:8 Time-Restricted Feeding (TRF)Pairwise-matched control participants practicing a fluid-permitted, 16-hour daily fasting window observed concurrently during the same calendar period |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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].
Key inclusion criteria (12 listed)
- 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]
Key exclusion criteria (7 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramadan 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 | Behavioural | Arm A: Ramadan Dry Fasting |
| 16:8 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 | Behavioural | Arm B: 16:8 Time-Restricted Feeding |
Primary outcome
Between-arm difference in PINK1 and Parkin mitophagy gene expression
Time frame: Change from baseline (Day -3) to Day 30 of the fasting period
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).
Between-arm difference in mitochondrial DNA copy number (mtCN)
Time frame: Change from baseline (Day -3) to Day 30 of the fasting period
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 38848455Sarkar 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.
- Background: PubMed 32914566Dillard 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Berna Uzun study chair
Operational Research Institute in Healthcare, Near East University, Nicosia, TRNC, Mersin 10, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitochondrial Degradation and Autophagy, run by Bahcesehir Cyprus University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Ibrahim Shuaibu, MD, Msc (+905338730889, ibrahim.shuaibu@baucyprus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-arm difference in PINK1 and Parkin mitophagy gene expression (time frame: Change from baseline (Day -3) to Day 30 of the fasting period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07638696, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.