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Many preclinical studies have demonstrated the beneficial effects of intermittent fasting (IF) in a wide range of neurological and cardiovascular diseases. This pilot study aims to investigate the safety and compliance as well as efficacy of one specific IF intervention called time-restricted feeding (TRF; 16 hours fasting daily) in patients with acute ischemic stroke (AIS).
Specific Aims This project is to conduct a pilot, phase II randomized clinical trial which aims to investigate the safety and compliance as well as efficacy of one specific IF intervention called time-restricted feeding (TRF; 16 hours fasting daily) in patients with acute ischemic stroke (AIS) The primary endpoint is the safety and compliance of 4 weeks of TRF in AIS patients.
The secondary endpoints are the efficacy of 4 weeks of TRF compared to normal eating (NE) on plasma and imaging biomarkers and functional outcome at 3 months post-stroke.
This study will determine whether compared to NE control:
(4) TRF improves diffusion tensor imaging on MRI at 3 months post stroke compared to baseline and NE in AIS patients.
(5) TRF changes plasma exosome components, metabolomics and lipidomics compared to baseline and NE in AIS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary counseling alone | No Intervention |
| |
| Time-restricted feeding (TRF) with dietary counseling | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted feeding (TRF) with dietary counseling | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE) |
| 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 3 months functional outcome, defined as modified Rankin Scale (mRS) <=1 as good outcome | Good functional outcome defined as modified Rankin Scale <=1. | 3 months |
| Diffusion tensor imaging on MRI at baseline and 3 months post stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung-Chun Tang, MD. PhD | Contact | 886-9-23562357 | sctang@ntuh.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 1010 | Taiwan |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| D010349 | Patient Compliance |
| D000083242 | Ischemic Stroke |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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|
To evaluate the changes of diffusion tensor imaging on MRI at 3 months post stroke in TRF compared to baseline and NE in acute ischemic stroke patients.
| 3 months |
| D015438 | Health Behavior |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |