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

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04184076
• Other study ID #: 201903100RINA
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2019
• Source: National Taiwan University Hospital
• Contact: Sung-Chun Tang, MD. PhD
• Phone: 886-9-23562357
• Email: sctang[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasting
• Ischemia
• Stroke

Intervention

Behavioral:
• Time-restricted feeding (TRF) with dietary counseling
Subjects will be instructed to administer time-restricted feeding. Subjects have to compete a 3-d food record, including 2 regular day and 1 holiday. At baseline, a dietitian will provide 15 min of instruction to each participant on how to complete the food records. Subjects will be asked to measure the volume of foods consumed with household measures. The timing of food intake will be also recorded. Food records will be collected each week during the experiment and will be reviewed by the dietitian for accuracy and completeness. A database for food content will be used to calculate the total daily intake of energy, fat, protein, carbohydrate, cholesterol, and fiber. All subjects will be asked to maintain their level of physical activity throughout the entire trial. Blood withdraw will be performed prior to the first consumption of food and analyze some biochemistry data.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)	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.; Stroke recurrence is defined as newly developed neurological deficit due to acute cerebrovascular insult during the study period.; 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	4 weeks
Secondary	3 months functional outcome, defined as modified Rankin Scale (mRS) <=1 as good outcome	Good functional outcome defined as modified Rankin Scale <=1.	3 months
Secondary	Diffusion tensor imaging on MRI at baseline and 3 months post stroke	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.	3 months