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Recruiting NCT06704321

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

No phase Interventional Non-Alcoholic Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TOTUM-448, Placebo.
Who it may be relevant to
Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Interventions

  • Dietary supplement TOTUM-448
    16 weeks of TOTUM-448 supplementation (4.284g/day corresponding to 8 capsules per day)
  • Dietary supplement Placebo
    16 weeks of placebo supplementation (8 capsules per day)

Primary outcome measures

  • Evolution of liver fat content [Time frame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)]
Secondary outcome measures (12)
  • Evolution of 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 [Time frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of liver health [Time frame: Screening (V0), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of inflammation [Time frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of anthropometric variables [Time frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of body composition [Time frame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of health-related quality of life [Time frame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of hepatic function [Time frame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of kidney function [Time frame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of hemodynamic measurements [Time frame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of complete blood count [Time frame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]
  • Evolution of thyroid stimulating hormone [Time frame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Canada · 1 center
  • Institut sur la nutrition et les aliments fonctionnels (INAF) — Québec

Identifiers

NCT: NCT06704321 · 2022-497

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗