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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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
St Paul's Hospital
Vancouver, British Columbia, Canada
RECRUITINGPlasma HDL
Maximum Plasma Concentration \[Cmax\] HDL (mmol)
Time frame: 14 days
WBC
Absolute count (cells per microliter)
Time frame: 14 days
Cytokines
Maximum Plasma Concentration \[Cmax\] plasma IL-6, IL-8, IL-10
Time frame: 14 days
28-day survival
28-day survival
Time frame: 28 days
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