Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients

Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients

Sponsors

Lead Sponsor: Qingdao University

Source Qingdao University
Brief Summary

In the nutrition guideline (A.S.P.E.N guideline), there was no recommendation about the feeding type in enteral feeding of critically ill patients. Continuous feeding is the most popular feeding type in ICU because of its less nursing burden and reducing the aspiration incidence theoretically. However, some previous studies demonstrated that there were no complications differences between continuous and time-restricted feedings(such as intermittent feedings).

In ICU, the disorder of protein synthesis is a universal problem and is associated with ICU acquired weakness. Time-restricted feeding is more physical than continuous feeding. In some animal researches, time-restricted feeding was proved to have a greater stimulatory effect on protein synthesis than continuous feeding. Besides of light, time-restricted feeding can may also adjust the biological rhythms. It is known that biological clocks could affect energy metabolism, emotion and so on. Until now, there are no enough clinical studies to prove the advantages in time-restricted feeding in ICU patients.So researchers designed the study to compare the time-restricted feeding and continuous feeding effect(especially protein synthesis) on ICU patients.

Detailed Description

Enteral nutrition support can be administered by continuous administration or by time-restricted administration in ICU. Continuous feeding is the most popular feeding schedule because of its less nursing burden and reducing the aspiration prevalence theoretically. However, previous studies demonstrated that there was no complications (diarrhea, distension, Ventilator associated pneumonia-VAP incidence, and so on) difference between these two feeding schedule. So in the nutrition guideline (A.S.P.E.N guideline), there was no recommendation about the feeding schedule. However, time-restricted feeding is more physical than continuous feeding. In ICU, the disorder of protein synthesis is a universal problem and is associated with ICU acquired weakness. In some animal researches, time-restricted feeding was proved to have a greater stimulatory effect on protein synthesis than continuous feeding.

Besides of light, time-restricted feeding can adjust the biological rhythms. It is known that biological clocks could affect energy metabolism, emotion and so on. In the "zi wu liu zhu" theory of traditional chinese medicine, feeding time should be at 7:00-9:00, 11:00-13:00 and 17:00-19:00. So researchers designed the study to compare the time-restricted feeding according to traditional chinese medicine and continuous feeding effect(especially protein synthesis) on ICU patients.

Overall Status Recruiting
Start Date May 9, 2018
Completion Date August 30, 2022
Primary Completion Date May 8, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
nitrogen balance at the time point of 10th feeding day
Secondary Outcome
Measure Time Frame
delirium up to 10 days
Gastric residual volume up to 10 days
diarrhea up to 10 days
Incidence of ventilator-associated pneumonia up to 10 days
glucose fluctuation up to 10 days
Albumin up to 10 days
Enrollment 380
Condition
Intervention

Intervention Type: Other

Intervention Name: time-restricted feeding

Description: At the beginning, all enrolled patients were fed by continuous feeding. When the amount calorie of feeding enteral nutritional suspension increased to 80% target calorie (target calorie: 25kilocalorie/kg.d), the patients was randomly into continuous feeding and time-restricted feeding group. In continuous feeding group, the enteral nutritional suspension was fed at constant speed for 24h.In the time restricted feeding, feeding time should be at 7:00-9:00, 11:00-13:00 and 17:00-19:00 at constant feeding speed.

Arm Group Label: time-restricted feeding

Intervention Type: Other

Intervention Name: continuous feeding

Description: At the beginning, all enrolled patients were fed by continuous feeding. When the amount calorie of feeding enteral nutritional suspension increased to 80% target calorie (target calorie: 25kilocalorie/kg.d), the patients was randomly into continuous feeding and time-restricted feeding group.In the continuous feeding, the total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h.

Arm Group Label: continuous feeding

Eligibility

Criteria:

Inclusion Criteria:

ICU patients asking for enteral nutrition by gastric tube

Exclusion Criteria:

Patients with gastrectomy; patients with enterectomy; patients with Gastrointestinal hemorrhage; patients with diabetes; patients with intestinal fistula

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
BO Yao, PHD Principal Investigator The Affiliated Hospital of Qingdao University
Overall Contact

Last Name: Bo Yao, PHD

Phone: +86053282912221

Email: [email protected]

Location
Facility: Status: Contact: The affiliated hospital of qingdao university BO YAO, PHD +86 053282912221 [email protected]
Location Countries

China

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Qingdao University

Investigator Full Name: Bo Yao,phD

Investigator Title: Clinician of intensive care unit, Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: continuous feeding

Type: Other

Description: The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h

Label: time-restricted feeding

Type: Other

Description: The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 6h (7:00-9:00,11:00-13:00,17:00-19:00).

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov