Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute ischemic stroke onset within 10 days
- •Age between 20-80 years.
- •Mild stroke severity (NIH stroke scale ≤ 6).
排除标准
- •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.
研究组 & 干预措施
Dietary counseling alone
- Controls will be instructed to maintain their weight throughout the trial, and not to change their eating or physical activity habits. Controls will visit the research center on a weekly basis for weigh-ins. Body composition and metabolic disease risk variables will be assessed in control subjects every 12 weeks.
- Subjects will complete a 3-d food record (2 regular day and 1 holiday) each week during the experiment.
- The blood draws will be taken at approximately 11:00 am. The following analyzes will be measured in plasma samples: ketones, fasting glucose, fasting insulin, hemoglobin A1c, liver function, renal function, albumin, lipid profiles, MMP-9, IL-6, TNF-alpha, exosome markers (phospho-IRS1, phospho-Tau, Abeta1-42). Metabolomic and lipidomic analyses will be performed on the baseline and 3-month time point plasma samples.
Time-restricted feeding (TRF) with dietary counseling
- Subjects will be instructed to eat ad libitum from 10:00 to 18:00 h daily, and fast from 18:00 to 10:00 h daily. During the 8-h feeding window, there will be no restrictions on types or quantities of foods consumed. During the fasting period, subjects will be encouraged to drink plenty of water and will be permitted to consume energy-free beverages.
- Subjects will complete a 3-d food record (2 regular day and 1 holiday) each week during the experiment.
- The blood draws will be taken at approximately 11:00 am, especially prior to the first consumption of food by subjects in the TRF group. The following analyzes will be measured in plasma samples: ketones, fasting glucose, fasting insulin, hemoglobin A1c, liver function, renal function, albumin, lipid profiles, MMP-9, IL-6, TNF-alpha, exosome markers (phospho-IRS1, phospho-Tau, Abeta1-42). Metabolomic and lipidomic analyses will be performed on the baseline and 3-month time point plasma samples.
干预措施: Time-restricted feeding (TRF) with dietary counseling (Behavioral)
结局指标
主要结局
The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)
时间窗: 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
次要结局
- 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)