Intermittent Fasting Following Acute Ischemic Stroke

December 15, 2019 updated by: Chang Ho Hwang, Ulsan University Hospital

Intermittent Fasting Following Acute Ischemic Stroke: Prospective, Randomized, Parallel Group, Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Ulsan, Korea, Republic of, 682-714
        • Recruiting
        • Ulsan University Hospital
        • Contact:
        • Principal Investigator:
          • Chang Ho Hwang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Dietary supplement: Intermittent Fasting
The aforementioned intermittent fasting in arm/group descriptions.
No Intervention: Ad libitium
Participants will be allowed to have hospital meals and all the desired intake without time limit.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Surface electromyography
Time Frame: 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
1 day before the initiation of intervention, and 6 months after the stroke onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Korean-modified Barthel index
Time Frame: 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.
1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Mini mental status exam
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Mini mental status exam(minimum of 0 and maximum scores of 30); higher values and a better outcome.
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
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Beck depression inventory(minimum of 0 and maximum scores of 63); higher values and a worse outcome.
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
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Wecsler aphasia battery(minimum of 0 and maximum scores of 100); higher values and a better outcome.
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 Berg balance scale
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Berg balance scale(minimum of 0 and maximum scores of 56); higher values and a better outcome.
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 Functional Ambulation Category
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Functional Ambulation Category(minimum of 0 and maximum scores of 5); higher values and a better outcome.
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 Motricity Index
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Motricity Index(minimum of 0 and maximum scores of 99); higher values and a better outcome.
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 10m walking test
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
10m walking test
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 Grasping force (kg)
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Grasping force (kg)
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 9-hole pegboard
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
9-hole pegboard
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 Jebsen Taylor test
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Jebsen-Taylor Hand Function Test
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 Nottingham sensory scale
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Nottingham sensory scale(minimum of 0 and maximum scores of 20); higher values and a better outcome.
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 Arm motor Fugl-Mayer scale
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Arm motor Fugl-Mayer scale; wrist & hand/proximal arm(minimum of 0 and maximum scores of 24 and of 34, respectively ); higher values and a better outcome.
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 Stroke impact scale
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Hand motor, Stroke Impact Scale (minimum of 12 and maximum scores of 60); higher values and a better outcome.
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 Ashworth scale
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Ashworth scale; elbow, wrist, knee & ankle(minimum of 0 and maximum scores of 4); higher values and a worse outcome.
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 Knee joint kinesthesia
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
The smallest iso-kinetic angle from which the participants could detect any passive flexion or extension movement of their own knee, using Biodex; (minimum of 0 and maximum scores of 360 degree); higher values and a worse outcome.
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 Behavioral inatention test
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Behavioral inatention test(minimum of 0 and maximum scores of 146); higher values and a better outcome.
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 Apraxia screen of Tulia
Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Apraxia screen of (minimum of 0 and maximum scores of 12); higher values and a better outcome.
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 motor evoked potential
Time Frame: 1 day before the initiation of intervention, and 6 months after the stroke onset
Amplitude (uV) of motor evoked potential was recorded on abductor pollicis brevis and extentor digitorum brevis following trans-cranial magnetic stimulation for cortico-spinal excitability.
1 day before the initiation of intervention, and 6 months after the stroke onset
Change of Weight
Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Weight (Kg)
1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Change of Temperature
Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
temperature (Celsius)
1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Change of Serum glucose level
Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Serum glucose level (mg/ml)
1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Change of Hypoglycemia-related severity
Time Frame: every day following the start of intervention until 2 weeks of intervention
Assessment of hypoglycemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome.
every day following the start of intervention until 2 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ulsan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • chhwang11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Clinical Trials on Intermittent Fasting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings