Non-Alcoholic Fatty Liver Disease study: TOTUM-448
Official title Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
ClinicalTrials.gov ID: NCT06704321
What this study is testing
- What it's testing
- The study wants to find out whether taking TOTUM-448 twice a day can lower liver fat, improve heart‑related health factors, and affect gut bacteria in people with non‑alcoholic fatty liver disease.
- Who it's for
- It is looking for men and women who have non‑alcoholic fatty liver disease.
- What's involved
- Participants will take the TOTUM-448 supplement twice daily and may have blood tests, liver scans, and stool samples to check liver fat, heart‑health markers, and gut bacteria.
- Time commitment
- The study lasts for several weeks, with regular visits for tests and to take the supplement.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Main
- 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
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.