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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 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04184076
Study type Interventional
Source National Taiwan University Hospital
Contact Sung-Chun Tang, MD. PhD
Phone 886-9-23562357
Email sctang@ntuh.gov.tw
Status Not yet recruiting
Phase N/A
Start date January 1, 2020
Completion date December 31, 2022
View Details
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