NCT04184076

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fasting

Interventions

Type	Name	Description
BEHAVIORAL	Time-restricted feeding (TRF) with dietary counseling	1. Subjects will be instructed to administer time-restricted feeding. 2. 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. 3. Blood withdraw will be performed prior to the first consumption of food and analyze some biochemistry data.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-12-03
• Last updated: 2019-12-03

Locations

1 site across 1 country: Taiwan