Nutritional Supplement for Patients With Severe Infection (NUWISE)

University of British Columbia

Status: Enrolling

Conditions: Severe Infection

Treatments: Dietary Supplement: Lauric Acid and Berberine

Study type: Interventional

Funder types: Other

Identifiers

NCT05602324

H21-00109

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Lauric Acid and Berberine

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lauric Acid and Berberine

No-intervention

No Intervention group

Description:

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