Nutritional Supplement for Patients With Severe Infection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05602324

Acronym

NUWISE

Enrollment

Registered

2022-11-02

Start date

2021-10-01

Completion date

2023-09-30

Last updated

2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Infection

Keywords

dyslipidemia

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.

Interventions

DIETARY_SUPPLEMENTLauric 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma HDL	14 days	Maximum Plasma Concentration \[Cmax\] HDL (mmol)

Secondary

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

Countries

Canada

Contacts

Primary ContactLynda Lazosky

llazosky@providencehealth.bc.ca778-389-9074

Backup ContactNiki Boyd, PhD

boyd.niki@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026