Nutritional Supplement for Patients With Severe Infection (NUWISE)

October 31, 2022 updated by: john boyd, University of British Columbia
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, v6k 2a8
        • Recruiting
        • St Paul's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma HDL
Time Frame: 14 days
Maximum Plasma Concentration [Cmax] HDL (mmol)
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WBC
Time Frame: 14 days
Absolute count (cells per microliter)
14 days
Cytokines
Time Frame: 14 days
Maximum Plasma Concentration [Cmax] plasma IL-6, IL-8, IL-10
14 days
28-day survival
Time Frame: 28 days
28-day survival
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-00109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

we are in the process of developing a plan to share data from this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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