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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083831
• Other study ID #: QYFYEC2023-108
• Status: Recruiting
• Start date: October 7, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: Qingdao University
• Contact: bo yao, Dr.
• Phone: 0532-82912220
• Email: icuyaobo[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Critical Illness
• Feeding Patterns

Intervention

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.

Locations

Country	Name	City	State
China	The affiliated hospital of qingdao university	Qingdao	Shan Dong Province

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clock genes expression	Genes including BMAL1 CLOCK TIMELESS PER1 and so on	7 days feeding
Primary	Gut Flora Rhythm	a diversity including shannon index and so on	7 days feeding