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

NCT06083831 | Unknown

• 1 other identifier: QYFYEC2023-108
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Patterns; Critical Illness; Circadian Rhythm Disorders

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Continuous feeding group

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

Other: feeding type

Interventions

feeding type OTHER

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; Sequential feeding group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qingdao University: lead

Study Sites (1)

The affiliated hospital of qingdao university

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Feeding Behavior; Critical Illness; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• bo yao, Dr.

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

bo yao, Dr.

CONTACT

0532-82912220; icuyaobo@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: October 7, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

CN (1)