Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
Recruiting · Québec, Quebec
Always free
Study care at no cost to you
For your time and travel
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Men and women age 18 to 75 years
- •MASLD with a CAP Score of 288 dB/m or higher and liver stiffness results less than 8 kPa (Fibroscan®), corresponding to F0 to F1 fibrosis
- •BMI of 25 or higher and less than 40 kg/m², plus WC thresholds per the NAFLD Nomenclature consensus group (Rinella. 2023. Hepatology)
- •Body weight stable within ±5% over the last three months
🚫 You may not be able to join if…
- •Cannot safely do MRI, Fibroscan®, and DEXA (contraindications)
- •Has a metabolic disorder that could significantly affect glucose metabolism or blood fat levels, or could affect study results (as decided by the investigator)
- •Uncontrolled high blood pressure: systolic ≥160 mmHg and/or diastolic ≥100 mmHg
- •Has a history of atherosclerotic cardiovascular disease (ASCVD)
- •Uses medications that may affect study outcomes
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–75
- ✓A BMI around 25 or higher
- ✓Have Obesity / overweight or Fatty liver disease (NASH/MASH)
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06704321 · Locations: Quebec