70 Participants Needed

TOTUM-448 for Fatty Liver Disease

(CARDIO-LIVER Trial)

VS
Overseen ByVéronique Sapone, MSc

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

AM

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

Weight stable within ± 5% in the last three months
BMI ≥25 and <40 kg/m2 and WC thresholds according to the NAFLD Nomenclature consensus group
My liver is mostly healthy with minimal scarring.

Exclusion Criteria

I have a history of heart and blood vessel disease.
Contraindications to MRI, Fibroscan® and DEXA
Suffering from a metabolic disorder susceptible to significantly affect glucose metabolism or plasma lipid levels or that might affect the study outcomes according to the investigator
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Baseline measurements are taken before the start of supplementation

1 week
1 visit (in-person)

Treatment

Participants receive TOTUM-448 or placebo twice per day for 16 weeks

16 weeks
3 visits (in-person) at 8 weeks and 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • TOTUM-448
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Valbiotis

Lead Sponsor

Trials
13
Recruited
2,000+

Valbiotis Canada inc.

Collaborator

Trials
2
Recruited
90+

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborator

Trials
26
Recruited
6,300+

CHU de Quebec-Universite Laval

Collaborator

Trials
177
Recruited
110,000+

Laval University

Collaborator

Trials
439
Recruited
178,000+

Findings from Research

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder globally, often linked to obesity and insulin resistance, and is characterized by excess fat accumulation in the liver, primarily in the form of triglycerides.
Steatosis, the initial stage of NAFLD, is reversible through lifestyle changes, but if left untreated, it can progress to more severe liver conditions like steatohepatitis, fibrosis, and cirrhosis, highlighting the importance of early intervention.
Fatty Acids and Effects on In Vitro and In Vivo Models of Liver Steatosis.Vergani, L.[2019]
Vitamin E and pioglitazone have established efficacy in treating nonalcoholic steatohepatitis (NASH), a severe form of nonalcoholic fatty liver disease (NAFLD), but there are currently no approved pharmacotherapies for NAFLD itself.
Several innovative therapies targeting different pathways of NASH are in development, including agents like obeticholic acid and elafibranor, with four promising candidates currently undergoing phase 3 trials, which may provide new treatment options in the near future.
Current and future pharmacological therapies for NAFLD/NASH.Sumida, Y., Yoneda, M.[2023]
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in the USA, primarily linked to insulin resistance and obesity, leading to conditions like steatosis and cirrhosis.
Weight loss and pharmacologic treatments targeting insulin resistance are key strategies for managing NAFLD, with bariatric surgery showing effectiveness; however, no specific medications are approved yet, though thiazolidinediones and statins show promise in improving liver health.
Treatment of non-alcoholic fatty liver disease.Tolman, KG., Dalpiaz, AS.[2022]

References

1.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Fatty Acids and Effects on In Vitro and In Vivo Models of Liver Steatosis. [2019]
Current and future pharmacological therapies for NAFLD/NASH. [2023]
Treatment of non-alcoholic fatty liver disease. [2022]
Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. [2021]
5.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Clinical and prognostic value of metabolic disorders in non-alcoholic fatty liver disease]. [2021]
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