NUWISE: Nutritional Supplement for Patients With Severe Infection

• Sponsor: University of British Columbia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05602324
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Infection	Dietary Supplement: Lauric Acid and Berberine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nutritional Supplement for Patients With Severe Infection
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	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
No Intervention: No-intervention participants in this arm will receive no additional intervention, beyond standard of care

Outcome Measures

Primary Outcome Measures

1. Plasma HDL [14 days]

   Maximum Plasma Concentration [Cmax] HDL (mmol)

Secondary Outcome Measures

1. WBC [14 days]

   Absolute count (cells per microliter)

2. Cytokines [14 days]

   Maximum Plasma Concentration [Cmax] plasma IL-6, IL-8, IL-10

3. 28-day survival [28 days]

   28-day survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Paul's Hospital	Vancouver	British Columbia	Canada	v6k 2a8

Sponsors and Collaborators

• University of British Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: john boyd, Associate Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT05602324
• Other Study ID Numbers: H21-00109
• First Posted: Nov 2, 2022
• Last Update Posted: Nov 2, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by john boyd, Associate Professor, University of British Columbia: dyslipidemia
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

No Results Posted as of Nov 2, 2022