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

NCT06161948 | Completed DMC

• 1 other identifier: 2023AH040243
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Time Restricted Feeding

Outcome Measures

Primary Outcomes (1)

• Poor 90-day functional prognosis

  mRS ≥ 3 points

  Day 90 post-randomization

Secondary Outcomes (7)

• GCS score at discharge

  The day of Discharge, an average of 20 days

• NIHSS score at discharge

  The day of Discharge, an average of 20 days

• mRS score at discharge

  The day of Discharge, an average of 20 days

• Barthel index at discharge

  The day of Discharge, an average of 20 days

• 90-day Barthel Index

  Day 90 post-randomization

Other Outcomes (4)

• Adverse events during hospitalization

  From enrollment to discharge, an average of 20 days

• Serious adverse events during hospitalization

  From enrollment to discharge, an average of 20 days

• 28-day mortality rate

  From enrollment to Day 28 post-randomization

Study Arms (2)

Time-restricted group

EXPERIMENTAL

Time-restricted enteral nutrition therapy group

Other: Time-restricted enteral nutrition therapy group

Continuous group

OTHER

Continuous enteral nutrition control group

Other: Continuous enteral nutrition control group

Interventions

Time-restricted enteral nutrition therapy group 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.

Time-restricted group

Continuous enteral nutrition control group 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.

Continuous group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

Study Sites (1)

The first affliated hospital of Wannan medical college

Wuhu, China

Location

Related Publications (1)

• 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.

  PMID: 41339081 DERIVED

MeSH Terms

Conditions

Stroke; Intermittent Fasting

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Tao Yu, doctor

  First Affiliated Hospital of Wannan Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 8, 2023
• Study Start: January 15, 2024
• Primary Completion: July 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)