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

May 30, 2020 updated by: Bo Yao,phD, Qingdao University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The affiliated hospital of Qingdao university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: continuous feeding
The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h
Other: continuous feeding
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.
Other: time-restricted feeding
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).
Other: time-restricted feeding
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nitrogen balance
Time Frame: at the time point of 10th feeding day
it equal to Nitrogen intake minus Nitrogen output.Source of nitrogen intake is the enteral nutritional suspension, and the amount of nitrogen can be calculated according to the proportion of nitrogen in enteral nutritional suspension. Main nitrogen losses include urine and feces. The amount of nitrogen in urine and feces can be measured by clinical laboratory.
at the time point of 10th feeding day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delirium
Time Frame: up to 10 days
it is disorders of the mental state and medical condition. It can be evaluated by The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
up to 10 days
Gastric residual volume
Time Frame: up to 10 days
This index was to evaluate the feeding complications. Nurse can evaluate the volume by pumping the stomach tube with syringe to measure the gastric content amount.
up to 10 days
diarrhea
Time Frame: up to 10 days
This index was to evaluate the feeding complications. It is the condition of having at least three loose or liquid bowel movements each day.
up to 10 days
Incidence of ventilator-associated pneumonia
Time Frame: up to 10 days
This index was to evaluate the feeding complications. Ventilator-associated pneumonia (VAP) is a type of lung infection that occurs in people who are on mechanical ventilation breathing machines for at least 48 hours. The diagnosis of VAP varies among hospitals and providers but usually requires a new infiltrate on chest x-ray plus two or more other factors. These factors include temperature of >38 or <36 °C, a white blood cell count of >12 × 10^9/ml, purulent secretions from the airways in the lung, and/or reduction in gas exchange.
up to 10 days
glucose fluctuation
Time Frame: up to 10 days
This index was to evaluate the feeding complications. The glucose is measured at the 11:00, 15:00, 21:00, 1:00 and 5:00 five time points. The glucose fluctuation is the maximum glucose amount plus minimum glucose amount.
up to 10 days
Albumin
Time Frame: up to 10 days
Serum albumin is the main protein of human blood plasma. It can be measured by clinical laboratory.
up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao University

Investigators

  • Principal Investigator: BO Yao, PHD, The affiliated hospital of Qingdao university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2018

Primary Completion (Anticipated)

May 8, 2021

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YB201811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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