Nutritional Supplement for Patients With Severe Infection

Not Applicable

Recruiting

• Conditions: Severe Infection
• Interventions: Dietary Supplement: Lauric Acid and Berberine

• Registration Number: NCT05602324
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-04
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lauric Acid and Berberine	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

Primary Outcome Measures

Name	Time	Method
Plasma HDL	14 days	Maximum Plasma Concentration \[Cmax\] HDL (mmol)

Secondary Outcome Measures

Name	Time	Method
WBC	14 days	Absolute count (cells per microliter)
Cytokines	14 days	Maximum Plasma Concentration \[Cmax\] plasma IL-6, IL-8, IL-10
28-day survival	28 days	28-day survival

Trial Locations

Locations (1)

St Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada