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Intermittent Fasting Following Acute Ischemic Stroke

NCT ID: NCT03789409

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke Intermittent Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intermittent Fasting

Intervention Type DIETARY_SUPPLEMENT

The aforementioned intermittent fasting in arm/group descriptions.

Ad libitium

Participants will be allowed to have hospital meals and all the desired intake without time limit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intermittent Fasting

The aforementioned intermittent fasting in arm/group descriptions.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Ho Hwang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Ulsan University Hospital

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chang Ho Hwang

Role: CONTACT

Phone: +82-52-250-7210

Email: [email protected]

Facility Contacts

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Chang Ho Hwang, M.D., Ph.D.

Role: primary

Other Identifiers

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chhwang11

Identifier Type: -

Identifier Source: org_study_id