Intermittent Fasting Following Acute Ischemic Stroke

Not Applicable

• Conditions: Intermittent Fasting; Ischemic Stroke
• Interventions: Dietary Supplement: Intermittent Fasting

• Registration Number: NCT03789409
• Lead Sponsor: Ulsan University Hospital

Brief Summary

Despite numerous kinds of evidence on functional health and CNS protection of intermittent fasting after injuries were found in many brain-, and spinal cord-damaged animal models, there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral infarction. The aim of this study is to evaluate the neurological, functional and clinical efficacy of intermittent fasting in patients after acute ischemic stroke.

Detailed Description

In order to verify the validity and clinical efficacy of intermittent fasting for neurological and functional effects of ischemic cerebral infarction, the first ischemic stroke (diagnosed within 1 year through brain MRI / CT) patients will be randomly assigned to intermittent fasting group or control group. In both groups, physical therapy, occupational therapy and speech therapy will be provided during 3 hours in total a day. The intermittent fasting group should maintain intermittent fasting for no less than 12 hours or more every day during the rehabilitation period (at least 1 week), and the control group is able to eat all of the hospital meals and all the participants want without any time limit. The efficacy of intermittent fasting is to be verified by performing the electro-physiological tests and functional evaluations before participation, 1st week, 2nd weeks after participation, before discharge, 3 months, and 6 months after the stroke onset.

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Study Start: 2019-03-04
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-15
• Last Update Posted: 2019-12-17
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patients who was diagnosed first ischemic stroke within preceeding 1 year through brain MRI/CT

Exclusion Criteria

• Musculo-skeletal disease with limbs malformation or joint contracture
• Weigh more than 135 kg or taller than 195 cm
• Diabetes mellitus
• unstable patient in neurology
• Refusal of participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Fasting	Intermittent Fasting	Over rehabilitation treatment during and admission (at least 1 week), intermittent fasting (IF) for more than 12 hours (water can be allowed). For subgroup assignment, participants can choose IF1 (eat early in the evening and late in the morning) or Post-IF2 (eat the remaining two meals without breakfast), depending on own their faver.

Primary Outcome Measures

Name	Time	Method
Change of Surface electromyography	1 day before the initiation of intervention, and 6 months after the stroke onset	root mean square and root peak square of compound motor action potential

Secondary Outcome Measures

Name	Time	Method
Change of Korean-modified Barthel index	1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset	Korean version-Modified Barthel Index (minimum of 0 and maximum scores of 100); higher values and a better outcome.

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of