ClinicalTrials.gg
RecruitingNCT06083831Updated Oct 17, 2023

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

An observational study in Feeding Patterns, Critical Illness and Circadian Rhythm Disorders, sponsored by Qingdao University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Qingdao University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Feeding Patterns
  • Critical Illness
  • Circadian Rhythm Disorders
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's planned enrollment of 20 is below the median of 183 across 270 observational studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Qingdao University is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients newly admitted to ICU were eligible for inclusion.

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherfeeding 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.

06

What researchers measure

Primary outcomes

  1. clock genes expression

    Genes including BMAL1 CLOCK TIMELESS PER1 and so on

    Time frame: 7 days feeding

  2. Gut Flora Rhythm

    α diversity including shannon index and so on

    Time frame: 7 days feeding

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06083831
Lead sponsor
Qingdao University
Responsible party
Bo Yao,phD (Attending physician, The Affiliated Hospital of Qingdao University) — Principal investigator
First posted
Oct 16, 2023
Start date
Oct 7, 2023
Primary completion
Mar 1, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Oct 17, 2023

Study contacts

bo yao, Dr.
Contact
icuyaobo@126.com
0532-82912220
bo yao, Dr.
principal investigator · The Affiliated Hospital of Qingdao University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion