Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding (MITO FAST)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ibrahim Ibrahim Shuaibu, MD, Msc
- 전화번호: +905338730889
- 이메일: ibrahim.shuaibu@baucyprus.edu.tr
연구 장소
-
-
-
Nicosia, 키프로스
- Near East University
-
연락하다:
- Berna Uzun, Prof.
- 전화번호: +90 533 871 98 38
- 이메일: berna.uzun@neu.edu.tr
-
부수사관:
- Adanze Cynthia Nge
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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]
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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
|
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 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
|
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Between-arm difference in PINK1 and Parkin mitophagy gene expression
기간: 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).
|
Change from baseline (Day -3) to Day 30 of the fasting period
|
|
Between-arm difference in mitochondrial DNA copy number (mtCN)
기간: 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
|
Change from baseline (Day -3) to Day 30 of the fasting period
|
공동 작업자 및 조사자
수사관
- 연구 의자: Berna Uzun, Operational Research Institute in Healthcare, Near East University, Nicosia, TRNC, Mersin 10, Turkey
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Bahcesehir Cyprus University
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .