Nutritional Supplement for Patients With Severe Infection

NCT ID: NCT05602324

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Lauric Acid and Berberine

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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john boyd

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Paul's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Lynda Lazosky

Role: CONTACT

778-389-9074

Niki Boyd, PhD

Role: CONTACT

Facility Contacts

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john boyd

Role: primary

6047106713

Other Identifiers

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H21-00109

Identifier Type: -

Identifier Source: org_study_id

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