Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease

• Registration Number: NCT06704321
• Lead Sponsor: Valbiotis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evolution of liver fat content	Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)	Liver fat content measured by MRI

Secondary Outcome Measures

Name	Time	Method
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 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 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
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)

Trial Locations

Locations (1)

Institut sur la nutrition et les aliments fonctionnels (INAF); 🇨🇦 Québec, Quebec, Canada