Time-restricted Enteral Nutrition Versus Continuous Enteral Nutrition in Patients With Severe Stroke

NCT ID: NCT06161948

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-12-12

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Time-restricted group

Time-restricted enteral nutrition therapy group

Group Type: EXPERIMENTAL

Time-restricted enteral nutrition therapy group

Intervention Type: OTHER

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 group

Continuous enteral nutrition control group

Group Type: OTHER

Continuous enteral nutrition control group

Intervention Type: OTHER

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.

Interventions

Time-restricted enteral nutrition therapy group

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.

Intervention Type: OTHER

Continuous enteral nutrition control group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Yu, doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wannan Medical College

Locations

The first affliated hospital of Wannan medical college

Wuhu, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 41339081 (View on PubMed)

Other Identifiers

2023AH040243

Identifier Type: -

Identifier Source: org_study_id