Effects of TOTUM-448 on liver fat and cardiometabolic health in people with MASLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of TOTUM-448, a dietary supplement composed of five plant extracts and choline, taken twice daily, on liver fat content, cardiometabolic risk factors, and gut microbiota in men and women diagnosed with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). Participants will be assessed for liver stiffness and fat content using Fibroscan® and will be monitored for changes in their metabolic health. The study aims to provide insights into the potential benefits of this natural supplement in managing liver health and associated metabolic conditions.

Why it matters

Who can join: the full rules

Main Inclusion Criteria:

* Men and women aged between 18 and 75 years (including ranges);
* CAP Score ≥288dB/m with liver stiffness results \<8kPa (corresponding to F0 to F1 fibrosis score) assessed by Fibroscan®;
* BMI ≥25 and \<40 kg/m2 and WC thresholds according to the NAFLD Nomenclature consensus group (Rinella. 2023. Hepatology);
* Weight stable within ± 5% in the last three months.

Main Exclusion Criteria:

* 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;
* Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
* With a history of atherosclerotic cardiovascular disease (ASCVD);
* Taking medication which may affect the study outcomes;
* Alcohol consumption over ≥10 drinks/week for women and ≥15 drinks/week for men (women consuming more than 3 drinks/day and men consuming more than 4 drinks/day will also be excluded) or not agreeing to keep their alcohol consumption habits unchanged throughout the study.

Where it's running

• Institut sur la nutrition et les aliments fonctionnels (INAF)
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: André Marette, PhD — Laval University
• Study coordinator: Véronique Sapone, MSc
• Email: veronique.sapone@valbiotis.com
• Phone: +33 (0)6 75 32 66 59

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.