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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Time Restricted Feeding
• Intervention / Treatment: Other: Time-restricted enteral nutrition therapy group; Other: Continuous enteral nutrition control group

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 Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Wuhu, China
    • The first affliated hospital of Wannan medical college

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time-restricted group; Time-restricted enteral nutrition therapy group	Other: 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.
Other: Continuous group; Continuous enteral nutrition control group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor 90-day functional prognosis	mRS ≥ 3 points	Day 90 post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GCS score at discharge	Glasgow Coma Scale,the score ranges from 3-15. The lower the score, the greater the impairment of consciousness	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	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	The day of Discharge, an average of 20 days
Barthel index at discharge	Barthel index at discharge	The day of Discharge, an average of 20 days
90-day Barthel Index	90-day Barthel Index	Day 90 post-randomization
ICU length of stay	ICU length of stay	From admission to ICU to transfer out of ICU .an average of 11 days
Length of hospital stay	total length of stay	The day of Discharge, an average of 20 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events during hospitalization	Safety outcomes	From enrollment to discharge, an average of 20 days
Serious adverse events during hospitalization	Safety outcome	From enrollment to discharge, an average of 20 days
28-day mortality rate	Safety outcome	From enrollment to Day 28 post-randomization
90-day mortality rate.	Safety outcome	From enrollment to Day 90 post-randomization

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wannan Medical College
• Investigators: Principal Investigator: Tao Yu, doctor, First Affiliated Hospital of Wannan Medical College

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): July 12, 2025
• Study Completion (Actual): December 12, 2025

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Feeding Behavior; Fasting; Stroke; Intermittent Fasting
• Other Study ID Numbers: 2023AH040243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No