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

Valbiotis70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

TOTUM-448DIETARY_SUPPLEMENT

16 weeks of TOTUM-448 supplementation (4.284g/day corresponding to 8 capsules per day)

PlaceboDIETARY_SUPPLEMENT

16 weeks of placebo supplementation (8 capsules per day)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Institut sur la nutrition et les aliments fonctionnels (INAF)

Québec, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

Evolution of liver fat content

Liver fat content measured by MRI

Time frame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)

Secondary Outcomes

Evolution of lipid profile

Measurement of standard lipid profile

Time frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

Evolution of glucose homeostasis

Measurement of glucose homeostasis

Time frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

Evolution of liver health

Cap score assessed by Fibroscan

Time frame: Screening (V0), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

Evolution of inflammation

Measurement of hs-CRP in mg /L Measurement of IL-6, MCP-1, RANTES in pg/ml

Time frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

Evolution of anthropometric variables

Measurement of BMI in kg/m²

Time frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

Evolution of body composition

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)

Central Contacts

Véronique Sapone, MSc

CONTACT

+33 (0)6 75 32 66 59 veronique.sapone@valbiotis.com

Data from ClinicalTrials.gov

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