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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06083831
Other study ID # QYFYEC2023-108
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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