Non-Alcoholic Fatty Liver Disease
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTTOTUM-448
16 weeks of TOTUM-448 supplementation (4.284g/day corresponding to 8 capsules per day)
DIETARY_SUPPLEMENTPlacebo
16 weeks of placebo supplementation (8 capsules per day)
Sponsors
CHU de Quebec-Universite Laval
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Laval University
Valbiotis Canada inc.
Valbiotis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blinded, parallel, placebo-controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of liver fat content | Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3) | Liver fat content measured by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of glucose homeostasis | Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of glucose homeostasis |
| Evolution of liver health | Screening (V0), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Cap score assessed by Fibroscan |
| Evolution of inflammation | Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of hs-CRP in mg /L Measurement of IL-6, MCP-1, RANTES in pg/ml |
| Evolution of anthropometric variables | Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of BMI in kg/m² |
| Evolution of body composition | Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3) | Evolution of body composition (i.e. total and trunk fat mass, total and trunk lean body mass) measured by Dual Energy X-ray Absorptiometry (DEXA) |
| Evolution of health-related quality of life | Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3) | Health-related quality of life (HRQoF) assessed by Medical Outcome Study Short Form - 36 (MOS SF-36), a generic tool to measure and compare the HRQoL on study population. |
| Evolution of lipid profile | Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of standard lipid profile |
| Evolution of kidney function | Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of kidney assessment |
| Evolution of hemodynamic measurements | Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of systolic and diastolic blood pressure in mmHg |
| Evolution of complete blood count | Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of white blood cells, red blood cells, number of platelets, amount of hemoglobin in the blood, hematocrit, mean red blood volume, mean hemoglobin amount per red blood cell, mean amount of hemoglobin relative to the size of the cell per red blood cell |
| Evolution of thyroid stimulating hormone | Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of thyroid stimulating hormone |
| Evolution of adverse events (TEAE, STEAE, TEAE leading to investigational product discontinuation, TEAR) | Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Treatment-Emergent Adverse Events (TEAE), Serious-TEAE (STEAE), TEAE leading to investigational product discontinuation, Treatment-Emergent Adverse Reaction (TEAR) |
| Evolution of hepatic function | Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3) | Measurement of liver assessment |
Countries
Canada
Contacts
Primary ContactVéronique Sapone, MSc
Outcome results
None listed