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Dietary Supplement
TOTUM-448 for Fatty Liver Disease (CARDIO-LIVER Trial)
N/A
Recruiting
Led By André Marette, PhD
Research Sponsored by Valbiotis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CAP Score ≥288dB/m with liver stiffness results <8kPa (corresponding to F0 to F1 fibrosis score) assessed by Fibroscan®
Men and women aged between 18 and 75 years
Must not have
With a history of atherosclerotic cardiovascular disease (ASCVD)
Suffering from uncontrolled arterial hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (v1) and end of supplementation after 16 weeks of supplementation (v3)
Summary
This trial will study how a combination of plant extracts and choline, called TOTUM-448, taken twice a day, affects liver fat, heart disease risk factors, and gut bacteria in men
Who is the study for?
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.
What is being tested?
The trial tests TOTUM-448, which is a combination of five plant extracts and choline taken twice daily, against a placebo. It aims to see if it can reduce liver fat content, improve cardiometabolic risk factors, and alter gut microbiota in MASLD patients.
What are the potential side effects?
Potential side effects are not listed; however, as TOTUM-448 contains natural extracts and choline, possible side effects might include digestive discomfort or allergic reactions. The specific profile will be determined by the trial's findings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is mostly healthy with minimal scarring.
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I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of heart and blood vessel disease.
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My blood pressure is very high and not under control.
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I drink less than 10 (if woman) or 15 (if man) alcoholic drinks per week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening (v0), baseline (v1), following 8 weeks of supplementation (v2) and end of supplementation after 16 weeks of supplementation (v3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (v0), baseline (v1), following 8 weeks of supplementation (v2) and end of supplementation after 16 weeks of supplementation (v3)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evolution of liver fat content
Secondary study objectives
Evolution of adverse events (TEAE, STEAE, TEAE leading to investigational product discontinuation, TEAR)
Evolution of anthropometric variables
Evolution of body composition
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TOTUM-448Experimental Treatment1 Intervention
The experimental active arm will be supplemented with TOTUM-448 twice per day.
Group II: PlaceboPlacebo Group1 Intervention
The placebo comparator arm will be supplemented with a placebo twice per day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TOTUM-448
2023
N/A
~10
Find a Location
Who is running the clinical trial?
Valbiotis Canada inc.UNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
ValbiotisLead Sponsor
12 Previous Clinical Trials
1,947 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
10 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Institut universitaire de cardiologie et de pneumologie de Québec, University LavalOTHER
23 Previous Clinical Trials
4,243 Total Patients Enrolled
CHU de Quebec-Universite LavalOTHER
172 Previous Clinical Trials
109,605 Total Patients Enrolled
Laval UniversityOTHER
434 Previous Clinical Trials
178,471 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
82 Patients Enrolled for Non-alcoholic Fatty Liver Disease
André Marette, PhDPrincipal InvestigatorLaval University
2 Previous Clinical Trials
60 Total Patients Enrolled