Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients

Not Applicable

• Conditions: Fasting

• Registration Number: NCT04184076
• Lead Sponsor: National Taiwan University Hospital

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:

1. TRF (16 hours fasting daily) is safe and well-tolerated in patients with AIS.

2. 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.

(5) TRF changes plasma exosome components, metabolomics and lipidomics compared to baseline and NE in AIS patients.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-12-01
• Last Update Submitted: 2019-12-01
• Study First Posted: 2019-12-03
• Last Update Posted: 2019-12-03
• Study Start: 2020-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with acute ischemic stroke onset within 10 days
2. Age between 20-80 years.
3. Mild stroke severity (NIH stroke scale ≤ 6).

Exclusion Criteria

1. Large hemispheric (> 1/2 middle cerebral artery territory) or cerebellar (>3 cm in diameter) infarct
2. Receiving intravenous rt-PA (alteplase) or endovascular thrombectomy
3. Severe stenosis (> 50%) or occlusion of intra/extra cranial arteries corresponding to acute ischemic stroke territory.
4. Body mass index ≤ 24.
5. Active cancer.
6. Diabetes mellitus (ex. HbA1C > 7% or taking oral hypoglycemic agent or insulin)
7. Active gastrointestinal bleeding.
8. Active infection, concurrent steroid usage or specific endocrine disorders.
9. Pre-stroke modified Rankin Scale > 2
10. Not willing to participate the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)	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 Outcome Measures

Name	Time	Method
3 months functional outcome, defined as modified Rankin Scale (mRS) <=1 as good outcome	3 months	Good functional outcome defined as modified Rankin Scale \<=1.
Diffusion tensor imaging on MRI at baseline and 3 months post stroke	3 months	To evaluate the changes of diffusion tensor imaging on MRI at 3 months post stroke in TRF compared to baseline and NE in acute ischemic stroke patients.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan