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

Recruiting

• Conditions: Feeding Patterns; Circadian Rhythm Disorders; Critical Illness
• Interventions: Other: feeding type

• Registration Number: NCT06083831
• Lead Sponsor: Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-07
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-15
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-03-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sequential feeding group	feeding type	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.
Continuous feeding group	feeding type	Patients received continous feeding with a constant velocity by an enteral feeding pump over one day.

Primary Outcome Measures

Name	Time	Method
clock genes expression	7 days feeding	Genes including BMAL1 CLOCK TIMELESS PER1 and so on
Gut Flora Rhythm	7 days feeding	α diversity including shannon index and so on

Trial Locations

Locations (1)

The affiliated hospital of qingdao university; 🇨🇳 Qingdao, Shan Dong Province, China