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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Feeding Patterns; Circadian Rhythm Disorders
• Intervention / Treatment: Other: feeding type

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: bo yao, Dr.; Phone Number: 0532-82912220; Email: icuyaobo@126.com

Study Locations

• China
  • Shan Dong Province
    • Qingdao, Shan Dong Province, China, 266000
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Bo Yao, PHD; Phone Number: +8618661800691; Email: icuyaobo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ICU patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clock genes expression	Genes including BMAL1 CLOCK TIMELESS PER1 and so on	7 days feeding
Gut Flora Rhythm	α diversity including shannon index and so on	7 days feeding

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease Attributes; Critical Illness; Chronobiology Disorders
• Other Study ID Numbers: QYFYEC2023-108

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