NCT06704321 Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
| NCT ID | NCT06704321 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Valbiotis |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-01-31 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
André Marette, PhD
PRINCIPAL INVESTIGATOR
Laval University
Frequently Asked Questions
Who can join the NCT06704321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06704321 currently recruiting?
Yes, NCT06704321 is actively recruiting participants. Contact the research team at veronique.sapone@valbiotis.com for enrollment information.
Where is the NCT06704321 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT06704321 clinical trial?
NCT06704321 is sponsored by Valbiotis. The principal investigator is André Marette, PhD at Laval University. The trial plans to enroll 70 participants.