NCT03789409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

1.9 years

First QC Date

December 20, 2018

Last Update Submit

December 15, 2019

Conditions

Ischemic StrokeIntermittent Fasting

Outcome Measures

Primary Outcomes (1)

  • Change of Surface electromyography

    root mean square and root peak square of compound motor action potential

    1 day before the initiation of intervention, and 6 months after the stroke onset

Secondary Outcomes (1)

  • 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

Other Outcomes (22)

  • Change of Mini mental status exam

    1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

  • Change of Beck depression inventory

    1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

  • Change of Wecsler aphasia battery

    1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

  • +19 more other outcomes

Study Arms (2)

Intermittent Fasting

EXPERIMENTAL

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.

Dietary Supplement: Intermittent Fasting

Ad libitium

NO INTERVENTION

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

Interventions

Intermittent FastingDIETARY_SUPPLEMENT

The aforementioned intermittent fasting in arm/group descriptions.

Intermittent Fasting

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan University Hospital

Ulsan, 682-714, South Korea

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeIntermittent Fasting

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesFastingFeeding BehaviorBehavior

Study Officials

  • Chang Ho Hwang, M.D., Ph.D.

    Ulsan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Chang Ho Hwang

CONTACT

+82-52-250-7210chhwang1220ciba@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 28, 2018

Study Start

March 4, 2019

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)