Clinical trial NCT06704321: Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: MASLD
Cardiometabolic risk factors
Dietary supplement
Plant extracts
Polyphenols
Liver fat content
Magnetic Resonance Imaging
Overweight
Obesity
Glucose metabolism
Oral glucose tolerance test
Insulin sensitivity
Insulin secretion
Fibroscan
Health-related quality of Life
Body composition
Liver function
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
Collaborators: name: CHU de Quebec-Universite Laval
name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Laval University
name: Valbiotis Canada inc.
First posted: 2024-11-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blinded, parallel, placebo-controlled study.
Primary purpose: PREVENTION

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.

Primary outcomes:
measure: Evolution of liver fat content
timeFrame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)
Secondary outcomes:
measure: Evolution of lipid profile
timeFrame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of glucose homeostasis
timeFrame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of liver health
timeFrame: Screening (V0), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of inflammation
timeFrame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of anthropometric variables
timeFrame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of body composition
timeFrame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of health-related quality of life
timeFrame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of hepatic function
timeFrame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of kidney function
timeFrame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of hemodynamic measurements
timeFrame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of complete blood count
timeFrame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of thyroid stimulating hormone
timeFrame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
measure: Evolution of adverse events (TEAE, STEAE, TEAE leading to investigational product discontinuation, TEAR)
timeFrame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut sur la nutrition et les aliments fonctionnels (INAF)
state: Quebec
Study officials:
affiliation: Laval University
name: André Marette, PhD
role: PRINCIPAL_INVESTIGATOR
References: