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

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ClinicalTrials.gov Identifier: NCT03439618
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Bo Yao,phD, 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.


Condition or disease Intervention/treatment Phase
Feeding Behavior Other: time-restricted feeding Other: continuous feeding Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : May 8, 2021
Estimated Study Completion Date : August 30, 2022

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Albumin [ Time Frame: up to 10 days ]
    Serum albumin is the main protein of human blood plasma. It can be measured by clinical laboratory.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439618


Contacts
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Contact: Bo Yao, PHD +86053282912221 icuyaobo@126.com

Locations
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China, Shandong
The affiliated hospital of qingdao university Recruiting
Qingdao, Shandong, China, 266000
Contact: BO YAO, PHD    +86 053282912221    icuyaobo@126.com   
Sponsors and Collaborators
Qingdao University
Investigators
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Principal Investigator: BO Yao, PHD The Affiliated Hospital of Qingdao University
Publications of Results:

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Responsible Party: Bo Yao,phD, Clinician of intensive care unit, Principal Investigator, Qingdao University
ClinicalTrials.gov Identifier: NCT03439618    
Other Study ID Numbers: YB201811
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes