Actively Recruiting
Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
Led by Valbiotis · Updated on 2024-11-26
70
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
V
Valbiotis
Lead Sponsor
C
CHU de Quebec-Universite Laval
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged between 18 and 75 years
- CAP Score 68 dB/m with liver stiffness below 8 kPa (F0 to F1 fibrosis) measured by Fibroscan�ae
- Body mass index (BMI) between 25 and 40 kg/m2 with waist circumference meeting NAFLD consensus guidelines
- Stable body weight within �b1 5% over the past three months
You will not qualify if you...
- Contraindications to MRI, Fibroscan�ae, or DEXA scans
- Metabolic disorders significantly affecting glucose or lipid metabolism or study outcomes
- Uncontrolled high blood pressure (systolic 60 mmHg and/or diastolic 100 mmHg)
- History of atherosclerotic cardiovascular disease (ASCVD)
- Use of medications that may influence study outcomes
- Alcohol consumption exceeding 10 drinks/week for women or 15 drinks/week for men, or more than 3 drinks/day for women and 4 drinks/day for men
- Unwillingness to maintain stable alcohol consumption during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institut sur la nutrition et les aliments fonctionnels (INAF)
Québec, Quebec, Canada, G1V 0A6
Actively Recruiting
Research Team
V
Véronique Sapone, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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