Recruiting

Nutritional Supplement

Sponsor:

University of British Columbia

Code:

NCT05602324

Conditions

Severe Infection

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Lauric Acid and Berberine

Study Details

Brief summary:

This is a randomized trial testing a supplement that has been approved by Health Canada to support healthy cholesterol levels (i.e. high density lipoprotein (HDL) cholesterol). This trial is proposing to use this approved supplement to determine whether it is able to raise HDL cholesterol in patients treated in the intensive care unit (ICU) with severe infection who have detrimentally low levels of HDL cholesterol. Patients who present to the ICU with severe infection will be approached for consent. If they choose to participate, patients will be given usual care or a 150mL daily nutritional supplement containing lauric acid (15 ml) and Berberine (1000 mg) daily for 14 days. Participants will be followed during their stay in the ICU and will receive follow up phone calls at Day 28 and 90.

Conditions

Severe Infection

Study ID

NCT05602324

Start date

Oct 1, 2021

Status verified date

Oct, 2022

Completion date

Sep, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinical diagnosis of Sepsis
  • plasma high density lipoprotein levels less than 1 mM
  • receiving enteral nutrition

Exclusion Criteria:

• known pregnancy/intending to get pregnant within 28 days of enrollment in study

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lauric Acid and Berberine

Participants in this arm of the trial will receive 15 ml lauric acid and 1000 mg berberine daily (via feed tube) for the duration of time that they are receiving enteral feeding, up to a maximum time of 14 days

no intervention: No-intervention

participants in this arm will receive no additional intervention, beyond standard of care

Interventions

Lauric Acid and Berberine

intervention (15 ml lauric acid + 1000 mg berberine) will be provided daily to participants in this arm for the duration of time that they receive enteral nutrition for a period of 14 days maximum

Primary outcome measure

  • Plasma HDL [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Locations

St Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, v6k 2a8

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Nov 2, 2022

Last verified

Oct, 2022

Keywords

  • dyslipidemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-11-02.