TOTUM-448 for Fatty Liver Disease
(CARDIO-LIVER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not take medications that may affect the study outcomes, so you might need to stop certain medications. It's best to discuss your current medications with the trial team to see if they are allowed.
How is the treatment TOTUM-448 unique for fatty liver disease?
TOTUM-448 is unique because it is a novel treatment specifically being studied for fatty liver disease, a condition with no approved pharmacotherapy. Unlike other treatments that target insulin resistance or dyslipidemia, TOTUM-448 may offer a new approach, although specific details about its mechanism or components are not provided in the available research.12345
What is the purpose of this trial?
This clinical trial aims to investigate the effects of TOTUM-448, a mix of 5 plant extracts and choline, consumed at the daily regimen of two times per day, on liver fat content, cardiometabolic risk factors and gut microbiota among both men and women with MASLD.
Research Team
André Marette, PhD
Principal Investigator
Laval University
Eligibility Criteria
This trial is for men and women with MASLD, a condition related to Non-alcoholic Fatty Liver Disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline measurements are taken before the start of supplementation
Treatment
Participants receive TOTUM-448 or placebo twice per day for 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TOTUM-448
Find a Clinic Near You
Who Is Running the Clinical Trial?
Valbiotis
Lead Sponsor
Valbiotis Canada inc.
Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
CHU de Quebec-Universite Laval
Collaborator
Laval University
Collaborator