Clinical trial NCT04184076: Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients
Official title: Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasting
Keywords: fasting
safety
compliance
ischemic stroke
time restricted feeding
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)
timeFrame: 4 weeks
Secondary outcomes:
measure: 3 months functional outcome, defined as modified Rankin Scale (mRS) <=1 as good outcome
timeFrame: 3 months
measure: Diffusion tensor imaging on MRI at baseline and 3 months post stroke
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: