Nutritional Supplement for Patients With Severe Infection

Severe Infection Clinical Trial

— NUWISE  

Official title:

Nutritional Supplement for Patients With Severe Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602324
• Other study ID #: H21-00109
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 2023

Study information

• Verified date: October 2022
• Source: University of British Columbia
• Contact: Lynda Lazosky
• Phone: 778-389-9074
• Email: llazosky[@]providencehealth.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Severe Infection

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma HDL	Maximum Plasma Concentration [Cmax] HDL (mmol)	14 days
Secondary	WBC	Absolute count (cells per microliter)	14 days
Secondary	Cytokines	Maximum Plasma Concentration [Cmax] plasma IL-6, IL-8, IL-10	14 days
Secondary	28-day survival	28-day survival	28 days