StrokeNCT06161948
Time-restricted Enteral Nutrition Versus Continuous Enteral Nutrition in Patients With Severe Stroke
A study testing Time-restricted enteral nutrition therapy group in people with Stroke and Time Restricted Feeding, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
In patients with severe stroke whose GCS score is ≤12 points or NIHSS score is ≥11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ≥3 points) compared with continuous enteral nutrition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Time Restricted Feeding
- What is being tested?
- Time-restricted enteral nutrition therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 12 Dec 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and <80 years old;
- Cerebral parenchymal hemorrhage or cerebral infarction within 72 hours of onset;
- GCS score ≤12 points or NIHSS score ≥11 points on admission,
- Enteral nutrition is planned, and the estimated enteral nutrition treatment time is ≥7 days;
- Signed informed consent form.
Who cannot join
- Complete parenteral nutrition is required due to contraindications to enteral nutrition;
- After gastrectomy or intestinal resection;
- Enteral nutrition treatment has been performed for >12 hours;
- Accompanying diseases: a. Advanced cancer; b. Severe cardiac insufficiency [ejection fraction ≤ 50%]; c. Severe liver failure [Child Pugh score ≥ 7]; d. Severe renal failure [glomerular filtration] rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL])
- Have a history of mental illness or mRS ≥ 3 points;
- The patient's doctor or nutritional therapist believes that the plan is not in the best interest of the patient;
- During the patient's admission, death is inevitable, and there are underlying diseases that result in a survival time of <90 days;
- The patient participates in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Time-restricted Enteral Nutrition on the Prognosis of Severe Stroke Patients: a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial
In patients with severe stroke whose GCS score is ≤12 points or NIHSS score is ≥11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ≥3 points) compared with continuous enteral nutrition.
Read the detailed description
Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
- Conditions
- Stroke, Time Restricted Feeding
- Being tested
- Time-restricted enteral nutrition therapy group, Continuous enteral nutrition control group
- Medical subject headings
- Stroke, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted enteral nutrition therapy groupOther
Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.
Continuous enteral nutrition control groupOther
The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted group | Experimental | Time-restricted enteral nutrition therapy group Receives: Other: Time-restricted enteral nutrition therapy group |
| Continuous group | Other | Continuous enteral nutrition control group Receives: Other: Continuous enteral nutrition control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor 90-day functional prognosis
mRS ≥ 3 points
Measured: Day 90 post-randomization
Secondary outcomes (7)
GCS score at discharge
Glasgow Coma Scale,the score ranges from 3-15. The lower the score, the greater the impairment of consciousness
Measured: The day of Discharge, an average of 20 days
NIHSS score at discharge
NIH Stroke Scale,the score ranges from 0~42 points, and the higher the score, the more severe the nerve damage
Measured: The day of Discharge, an average of 20 days
mRS score at discharge
Modified Rankin Scale，the score ranges from 0~6 levels,and the higher the score, the more severe outcome
Measured: The day of Discharge, an average of 20 days
Barthel index at discharge
Barthel index at discharge
Measured: The day of Discharge, an average of 20 days
90-day Barthel Index
90-day Barthel Index
Measured: Day 90 post-randomization
ICU length of stay
ICU length of stay
Measured: From admission to ICU to transfer out of ICU .an average of 11 days
Length of hospital stay
total length of stay
Measured: The day of Discharge, an average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Jan 2024
- Primary completion12 Jul 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Yu, doctor, Principal investigator, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161948
- Sponsor's protocol ID
- 2023AH040243
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu T, Shi G, Ye Z, Jiang X, Jia W, Wang Y, Wang Y, Xu J. Rationale and design of a PROBE trial comparing continuous enteral nutrition to time-restricted enteral nutrition in severe stroke. Stroke Vasc Neurol. 2025 Dec 3:svn-2025-004382. doi: 10.1136/svn-2025-004382. Online ahead of print.
PubMed 41339081
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-restricted Enteral Nutrition on the Prognosis of Severe Stroke Patients: a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial
- ClinicalTrials.gov ID
- NCT06161948
- Acronym / sponsor ID
- 2023AH040243
- Conditions
- Stroke, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 8 Dec 2023 (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.
In patients with severe stroke whose GCS score is ≤12 points or NIHSS score is ≥11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ≥3 points) compared with continuous enteral nutrition.
Detailed description
Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted group | Experimental | Other: Time-restricted enteral nutrition therapy groupTime-restricted enteral nutrition therapy group |
| Continuous group | Other | Other: Continuous enteral nutrition control groupContinuous enteral nutrition control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old and <80 years old;
- Cerebral parenchymal hemorrhage or cerebral infarction within 72 hours of onset;
- GCS score ≤12 points or NIHSS score ≥11 points on admission,
- Enteral nutrition is planned, and the estimated enteral nutrition treatment time is ≥7 days;
- Signed informed consent form.
Key exclusion criteria (8 listed)
- Complete parenteral nutrition is required due to contraindications to enteral nutrition;
- After gastrectomy or intestinal resection;
- Enteral nutrition treatment has been performed for >12 hours;
- Accompanying diseases: a. Advanced cancer; b. Severe cardiac insufficiency [ejection fraction ≤ 50%]; c. Severe liver failure [Child Pugh score ≥ 7]; d. Severe renal failure [glomerular filtration] rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL])
- Have a history of mental illness or mRS ≥ 3 points;
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 enteral nutrition therapy groupControl the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first. | Other | Time-restricted group |
| Continuous enteral nutrition control groupThe control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first. | Other | Continuous group |
Primary outcome
Poor 90-day functional prognosis
Time frame: Day 90 post-randomization
mRS ≥ 3 points
7 secondary outcomes
GCS score at discharge
Time frame: The day of Discharge, an average of 20 days
NIHSS score at discharge
Time frame: The day of Discharge, an average of 20 days
mRS score at discharge
Time frame: The day of Discharge, an average of 20 days
Barthel index at discharge
Time frame: The day of Discharge, an average of 20 days
90-day Barthel Index
Time frame: Day 90 post-randomization
ICU length of stay
Time frame: From admission to ICU to transfer out of ICU .an average of 11 days
Length of hospital stay
Time frame: The day of Discharge, an average of 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 41339081Yu T, Shi G, Ye Z, Jiang X, Jia W, Wang Y, Wang Y, Xu J. Rationale and design of a PROBE trial comparing continuous enteral nutrition to time-restricted enteral nutrition in severe stroke. Stroke Vasc Neurol. 2025 Dec 3:svn-2025-004382. doi: 10.1136/svn-2025-004382. Online ahead of print.
- 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.
Tao Yu, doctor principal investigator
First Affiliated Hospital of Wannan Medical College
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 enteral nutrition therapy group in people with Stroke and Time Restricted Feeding, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jan 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor 90-day functional prognosis (time frame: Day 90 post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06161948, which also lists 1 linked publication.
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 2 Jan 2026.