FastingNCT04184076
Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients
A study testing Time-restricted feeding (TRF) with dietary counseling in people with Fasting, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fasting
- What is being tested?
- Time-restricted feeding (TRF) with dietary counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute ischemic stroke onset within 10 days
- Age between 20-80 years.
- Mild stroke severity (NIH stroke scale ≤ 6).
Who cannot join
- Large hemispheric (> 1/2 middle cerebral artery territory) or cerebellar (>3 cm in diameter) infarct
- Receiving intravenous rt-PA (alteplase) or endovascular thrombectomy
- Severe stenosis (> 50%) or occlusion of intra/extra cranial arteries corresponding to acute ischemic stroke territory.
- Body mass index ≤ 24.
- Active cancer.
- Diabetes mellitus (ex. HbA1C > 7% or taking oral hypoglycemic agent or insulin)
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- Active gastrointestinal bleeding.
- Active infection, concurrent steroid usage or specific endocrine disorders.
- Pre-stroke modified Rankin Scale > 2
- Not willing to participate the trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 1010
Sung-Chun Tang, MD. PhD
About this study
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).
Read the detailed description
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:
- TRF (16 hours fasting daily) is safe and well-tolerated in patients with AIS.
- 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
- Fasting
- Being tested
- Time-restricted feeding (TRF) with dietary counseling
- Keywords
- fasting, safety, compliance, ischemic stroke, time restricted feeding
- Medical subject headings
- Fasting, Patient Compliance, Ischemic Stroke, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted feeding (TRF) with dietary counselingBehavioural
- Subjects will be instructed to administer time-restricted feeding.
- 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.
- Blood withdraw will be performed prior to the first consumption of food and analyze some biochemistry data.
| Study group | Role | What they receive |
|---|---|---|
| Dietary counseling alone | No intervention | 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. |
| Time-restricted feeding (TRF) with dietary counseling | Experimental | 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. Receives: Behavioral: Time-restricted feeding (TRF) with dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)
- Stroke in-evolution is defined as an increase in the NIHSS score of ≥2 points compared to initial score or the lowest score during admission, excluding other attributable medical or systemic causes.
- Stroke recurrence is defined as newly developed neurological deficit due to acute cerebrovascular insult during the study period.
- Hypoglycemia event is defined as symptomatic hypoglycemia fulfilling the criteria of Whipple's triad as symptoms known or likely to be caused by hypoglycemia, a low plasma glucose (< 60 mg/dl) measured at the time of the symptoms and relief of symptoms when the glucose is raised to normal
Measured: 4 weeks
Secondary outcomes (2)
3 months functional outcome, defined as modified Rankin Scale (mRS) <=1 as good outcome
Good functional outcome defined as modified Rankin Scale <=1.
Measured: 3 months
Diffusion tensor imaging on MRI at baseline and 3 months post stroke
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184076
- Sponsor's protocol ID
- 201903100RINA
- Status last verified
- Jul 2019
- First submitted
- 17 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT04184076
- Acronym / sponsor ID
- 201903100RINA
- Conditions
- Fasting
- Keywords
- fasting, safety, compliance, ischemic stroke, time restricted feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- TRF (16 hours fasting daily) is safe and well-tolerated in patients with AIS.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary counseling alone | No intervention | –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. |
| Time-restricted feeding (TRF) with dietary counseling | Experimental | Behavioral: Time-restricted feeding (TRF) with dietary counseling1. 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with acute ischemic stroke onset within 10 days
- Age between 20-80 years.
- Mild stroke severity (NIH stroke scale ≤ 6).
Key exclusion criteria (10 listed)
- Large hemispheric (> 1/2 middle cerebral artery territory) or cerebellar (>3 cm in diameter) infarct
- Receiving intravenous rt-PA (alteplase) or endovascular thrombectomy
- Severe stenosis (> 50%) or occlusion of intra/extra cranial arteries corresponding to acute ischemic stroke territory.
- Body mass index ≤ 24.
- Active cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted feeding (TRF) with dietary counseling1. 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. | Behavioural | Time-restricted feeding (TRF) with dietary counseling |
Primary outcome
The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE)
Time frame: 4 weeks
1. Stroke in-evolution is defined as an increase in the NIHSS score of ≥2 points compared to initial score or the lowest score during admission, excluding other attributable medical or systemic causes. 2. Stroke recurrence is defined as newly developed neurological deficit due to acute cerebrovascular insult during the study period. 3. Hypoglycemia event is defined as symptomatic hypoglycemia fulfilling the criteria of Whipple's triad as symptoms known or likely to be caused by hypoglycemia, a low plasma glucose (< 60 mg/dl) measured at the time of the symptoms and relief of symptoms when the glucose is raised to normal
2 secondary outcomes
3 months functional outcome, defined as modified Rankin Scale (mRS) <=1 as good outcome
Time frame: 3 months
Diffusion tensor imaging on MRI at baseline and 3 months post stroke
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted feeding (TRF) with dietary counseling in people with Fasting, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung-Chun Tang, MD. PhD (886-9-23562357, sctang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The events of stroke in-evolution, stroke recurrence and hypoglycemia in acute ischemic stroke patients with time restricted fasting (TRF) or normal eating (NE) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.