Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)
Study Overview
Brief Summary
Many preclinical studies have demonstrated the beneficial effects of intermittent fasting (IF) in a wide range of neurological and cardiovascular diseases. This pilot study aims to investigate the safety and compliance as well as efficacy of one specific IF intervention called time-restricted feeding (TRF; 16 hours fasting daily) in patients with acute ischemic stroke (AIS).
Detailed Description
Specific Aims This project is to conduct a pilot, phase II randomized clinical trial which aims to investigate the safety and compliance as well as efficacy of one specific IF intervention called time-restricted feeding (TRF; 16 hours fasting daily) in patients with acute ischemic stroke (AIS) The primary endpoint is the safety and compliance of 4 weeks of TRF in AIS patients.
The secondary endpoints are the efficacy of 4 weeks of TRF compared to normal eating (NE) on plasma and imaging biomarkers and functional outcome at 3 months post-stroke.
This study will determine whether compared to NE control:
- TRF (16 hours fasting daily) is safe and well-tolerated in patients with AIS.
- TRF improves functional outcome compared to NE in AIS patients. (3) TRF decreases plasma pro-inflammatory cytokines including metallopeptidase (MMP)-9, interleukin (IL)-6, and tumor necrosis factor alpha (TNF) in plasma compared to baseline and NE in AIS patients.
(4) TRF improves diffusion tensor imaging on MRI at 3 months post stroke compared to baseline and NE in AIS patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with acute ischemic stroke onset within 10 days
- •Age between 20-80 years.
- •Mild stroke severity (NIH stroke scale ≤ 6).
Exclusion Criteria
- •Large hemispheric (> 1/2 middle cerebral artery territory) or cerebellar (>3 cm in diameter) infarct
- •Receiving intravenous rt-PA (alteplase) or endovascular thrombectomy
- •Severe stenosis (> 50%) or occlusion of intra/extra cranial arteries corresponding to acute ischemic stroke territory.
- •Body mass index ≤
- •Active cancer.
- •Diabetes mellitus (ex. HbA1C > 7% or taking oral hypoglycemic agent or insulin)
- •Active gastrointestinal bleeding.
- •Active infection, concurrent steroid usage or specific endocrine disorders.
- •Pre-stroke modified Rankin Scale > 2
- •Not willing to participate the trial.
Outcomes
Primary Outcomes
The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)
Time Frame: 4 weeks
1. Stroke in-evolution is defined as an increase in the NIHSS score of ≥2 points compared to initial score or the lowest score during admission, excluding other attributable medical or systemic causes. 2. Stroke recurrence is defined as newly developed neurological deficit due to acute cerebrovascular insult during the study period. 3. Hypoglycemia event is defined as symptomatic hypoglycemia fulfilling the criteria of Whipple's triad as symptoms known or likely to be caused by hypoglycemia, a low plasma glucose (\< 60 mg/dl) measured at the time of the symptoms and relief of symptoms when the glucose is raised to normal
Secondary Outcomes
- 3 months functional outcome, defined as modified Rankin Scale (mRS) <=1 as good outcome(3 months)
- Diffusion tensor imaging on MRI at baseline and 3 months post stroke(3 months)