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

Sponsor
Valbiotis
Study ID
NCT06704321
Status
Recruiting
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Conditions

  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Nov 26, 2024
Start date
Jan 31, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: TOTUM-448
    The experimental active arm will be supplemented with TOTUM-448 twice per day.
  • Placebo Comparator: Placebo
    The placebo comparator arm will be supplemented with a placebo twice per day.

Primary Outcome Measure

Evolution of liver fat content [ Time Frame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3) ]

Central Contacts

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