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

NCT06704321 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-11-26

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease

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)

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    collaborator OTHER

  • Laval University

    collaborator OTHER

  • Valbiotis Canada inc.

    collaborator UNKNOWN

  • Valbiotis

    lead INDUSTRY

Principal Investigators

  • André Marette, PhD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704321 on ClinicalTrials.gov