Effects of TOTUM-448 on liver fat and cardiometabolic health in people with MASLD
A Parallel, Randomized, Placebo-Controlled, Double-Blinded Clinical Trial of the Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Both Men and Women with MASLD
This study is testing if a new dietary supplement called TOTUM-448 can help reduce liver fat and improve heart and metabolic health in people with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Valbiotis Industry-sponsored |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06704321 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 18 to 75 with a BMI between 25 and 40, stable weight, and specific liver fat measurements.
Not a fit: Patients with significant metabolic disorders, uncontrolled hypertension, or a history of cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a novel dietary approach to reduce liver fat and improve cardiometabolic health in patients with MASLD.
How similar studies have performed: Other studies have shown promise in using plant extracts for liver health, but the specific formulation of TOTUM-448 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Québec, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.