Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients
NCT ID: NCT04184076
Last Updated: 2019-12-03
Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-01-01
2022-12-31
Brief Summary
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Detailed Description
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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:
1. TRF (16 hours fasting daily) is safe and well-tolerated in patients with AIS.
2. TRF improves functional outcome compared to NE in AIS patients. (3) TRF decreases plasma pro-inflammatory cytokines including metallopeptidase (MMP)-9, interleukin (IL)-6, and tumor necrosis factor alpha (TNF) in plasma compared to baseline and NE in AIS patients.
(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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dietary counseling alone
1. Controls will be instructed to maintain their weight throughout the trial, and not to change their eating or physical activity habits. Controls will visit the research center on a weekly basis for weigh-ins. Body composition and metabolic disease risk variables will be assessed in control subjects every 12 weeks.
2. Subjects will complete a 3-d food record (2 regular day and 1 holiday) each week during the experiment.
3. The blood draws will be taken at approximately 11:00 am. The following analyzes will be measured in plasma samples: ketones, fasting glucose, fasting insulin, hemoglobin A1c, liver function, renal function, albumin, lipid profiles, MMP-9, IL-6, TNF-alpha, exosome markers (phospho-IRS1, phospho-Tau, Abeta1-42). Metabolomic and lipidomic analyses will be performed on the baseline and 3-month time point plasma samples.
No interventions assigned to this group
Time-restricted feeding (TRF) with dietary counseling
1. Subjects will be instructed to eat ad libitum from 10:00 to 18:00 h daily, and fast from 18:00 to 10:00 h daily. During the 8-h feeding window, there will be no restrictions on types or quantities of foods consumed. During the fasting period, subjects will be encouraged to drink plenty of water and will be permitted to consume energy-free beverages.
2. Subjects will complete a 3-d food record (2 regular day and 1 holiday) each week during the experiment.
3. The blood draws will be taken at approximately 11:00 am, especially prior to the first consumption of food by subjects in the TRF group. The following analyzes will be measured in plasma samples: ketones, fasting glucose, fasting insulin, hemoglobin A1c, liver function, renal function, albumin, lipid profiles, MMP-9, IL-6, TNF-alpha, exosome markers (phospho-IRS1, phospho-Tau, Abeta1-42). Metabolomic and lipidomic analyses will be performed on the baseline and 3-month time point plasma samples.
Time-restricted feeding (TRF) with dietary counseling
1. Subjects will be instructed to administer time-restricted feeding.
2. Subjects have to compete a 3-d food record, including 2 regular day and 1 holiday. At baseline, a dietitian will provide 15 min of instruction to each participant on how to complete the food records. Subjects will be asked to measure the volume of foods consumed with household measures. The timing of food intake will be also recorded. Food records will be collected each week during the experiment and will be reviewed by the dietitian for accuracy and completeness. A database for food content will be used to calculate the total daily intake of energy, fat, protein, carbohydrate, cholesterol, and fiber. All subjects will be asked to maintain their level of physical activity throughout the entire trial.
3. Blood withdraw will be performed prior to the first consumption of food and analyze some biochemistry data.
Interventions
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Time-restricted feeding (TRF) with dietary counseling
1. Subjects will be instructed to administer time-restricted feeding.
2. Subjects have to compete a 3-d food record, including 2 regular day and 1 holiday. At baseline, a dietitian will provide 15 min of instruction to each participant on how to complete the food records. Subjects will be asked to measure the volume of foods consumed with household measures. The timing of food intake will be also recorded. Food records will be collected each week during the experiment and will be reviewed by the dietitian for accuracy and completeness. A database for food content will be used to calculate the total daily intake of energy, fat, protein, carbohydrate, cholesterol, and fiber. All subjects will be asked to maintain their level of physical activity throughout the entire trial.
3. Blood withdraw will be performed prior to the first consumption of food and analyze some biochemistry data.
Eligibility Criteria
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Inclusion Criteria
2. Age between 20-80 years.
3. Mild stroke severity (NIH stroke scale ≤ 6).
Exclusion Criteria
2. Receiving intravenous rt-PA (alteplase) or endovascular thrombectomy
3. Severe stenosis (\> 50%) or occlusion of intra/extra cranial arteries corresponding to acute ischemic stroke territory.
4. Body mass index ≤ 24.
5. Active cancer.
6. Diabetes mellitus (ex. HbA1C \> 7% or taking oral hypoglycemic agent or insulin)
7. Active gastrointestinal bleeding.
8. Active infection, concurrent steroid usage or specific endocrine disorders.
9. Pre-stroke modified Rankin Scale \> 2
10. Not willing to participate the trial.
20 Years
80 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Sung-Chun Tang, MD. PhD
Role: primary
Other Identifiers
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201903100RINA
Identifier Type: -
Identifier Source: org_study_id
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