The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients

Sponsor
Qingdao University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06083831
Collaborator
(none)
20
1
6.8
2.9

Study Details

Study Description

Brief Summary

Circadian rhythms plays an important role for healthy. And critical illness contributes to the disruption of circadian rhythms. Not only right but also feeding can affect the circadian clock gene expression. In a investigators' previous study, some metabolic indicators (the albumin level, total cholesterol level and total bile acid level) and the increases in lymphocyte counts in the sequential feeding group were different from those in the continuous feeding group. Investigators think sequential feeding may adjust circadian clock gene expression for its effect on metabolism and immunity. Moreover, sequential feeding did alter the abundances of some gut microbes to some degree in the investigators' previous study. Investigators think sequential feeding may adjust gut flora rhythms.

Condition or Disease Intervention/Treatment Phase
  • Other: feeding type

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients
Actual Study Start Date :
Oct 7, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Sequential feeding group

After achieving ≥80% of the nutrition target calories (25-30 kcal/kg/d) by continuous feeding, continuous feeding was changed into intermittent feeding. The total daily dosage of enteral nutrition was equally distributed during three periods at 7-9:00, 11-13:00 and 17-19:00. The enteral nutritional suspension administered during each period was given at a uniform rate within two hours by an enteral feeding pump. The other times of the day were fasting times.

Other: feeding type
In our department, the ICU patients received continuous feeding or sequential feeding. Patients received continuous feeding with a constant velocity by an enteral feeding pump over one day. In sequential feeding type, after achieving ≥80% of the nutrition target calories (25-30 kcal/kg/d), the patients received intermittent feeding. The total daily dosage of enteral nutrition was equally distributed during three periods at 7-9:00, 11-13:00 and 17-19:00. The enteral nutritional suspension administered during each period was given at a uniform rate within two hours by an enteral feeding pump. The other times of the day were fasting times.

Continuous feeding group

Patients received continous feeding with a constant velocity by an enteral feeding pump over one day.

Other: feeding type
In our department, the ICU patients received continuous feeding or sequential feeding. Patients received continuous feeding with a constant velocity by an enteral feeding pump over one day. In sequential feeding type, after achieving ≥80% of the nutrition target calories (25-30 kcal/kg/d), the patients received intermittent feeding. The total daily dosage of enteral nutrition was equally distributed during three periods at 7-9:00, 11-13:00 and 17-19:00. The enteral nutritional suspension administered during each period was given at a uniform rate within two hours by an enteral feeding pump. The other times of the day were fasting times.

Outcome Measures

Primary Outcome Measures

  1. clock genes expression [7 days feeding]

    Genes including BMAL1 CLOCK TIMELESS PER1 and so on

  2. Gut Flora Rhythm [7 days feeding]

    α diversity including shannon index and so on

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients newly admitted to ICU were eligible for inclusion.
Exclusion Criteria:
  • An estimated feeding time of less than 10 days in ICU;

  • Diabetes;

  • Gastrointestinal disease (gastrointestinal surgery, gastrointestinal bleeding, pancreatitis, Crohn's disease, ulcerative colitis, irritable bowel syndrome);

  • Inability to tolerate ≥80% of the nutrition target calories (25-30 kcal/kg/d) with enteral feeding through gastric tube;

  • The ability to eat orally at admission.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The affiliated hospital of qingdao university Qingdao Shan Dong Province China 266000

Sponsors and Collaborators

  • Qingdao University

Investigators

  • Principal Investigator: bo yao, Dr., The Affiliated Hospital of Qingdao University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bo Yao,phD, Attending physician, The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT06083831
Other Study ID Numbers:
  • QYFYEC2023-108
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2023