Intermittent Fasting Following Acute Ischemic Stroke

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: Unknown
• Conditions: Ischemic Stroke; Intermittent Fasting
• Intervention / Treatment: Dietary supplement: Intermittent Fasting

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: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Recruiting
    • Ulsan University Hospital
    • Contact: Chang Ho Hwang, M.D., Ph.D.; Phone Number: +82-52-250-7210; Email: chhwang1220ciba@gmail.com
    • Principal Investigator: Chang Ho Hwang, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Korean-modified Barthel index	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

Outcome Measure	Measure Description	Time Frame
Change of Mini mental status exam	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	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	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	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	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	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	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)	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	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	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	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	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	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	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	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	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	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	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	Weight (Kg)	1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Change of Temperature	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	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	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

• Sponsor: Ulsan University Hospital
• Investigators: Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 15, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID 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