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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ibrahim Ibrahim Shuaibu, MD, Msc
- Número de teléfono: +905338730889
- Correo electrónico: ibrahim.shuaibu@baucyprus.edu.tr
Ubicaciones de estudio
-
-
-
Nicosia, Chipre
- Near East University
-
Contacto:
- Berna Uzun, Prof.
- Número de teléfono: +90 533 871 98 38
- Correo electrónico: berna.uzun@neu.edu.tr
-
Sub-Investigador:
- Adanze Cynthia Nge
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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]
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Between-arm difference in PINK1 and Parkin mitophagy gene expression
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Berna Uzun, Operational Research Institute in Healthcare, Near East University, Nicosia, TRNC, Mersin 10, Turkey
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Bahcesehir Cyprus University
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .