Recruiting

TOTUM-448

Sponsor:

Valbiotis

Code:

NCT06704321

Conditions

Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

TOTUM-448

Placebo

Study Details

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study ID

NCT06704321

Start date

Jan 31, 2024

Status verified date

Nov, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

TOTUM-448

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

Placebo

16 weeks of placebo supplementation (8 capsules 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 and Locations

Central contacts

Véronique Sapone, MSc

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

Locations

Institut sur la nutrition et les aliments fonctionnels (INAF)

Recruiting

Québec, Quebec, Canada, G1V 0A6

Contacts

Julie Marois, MSc

+1 (418) 656-2131julie.marois@fsaa.ulaval.ca

More Information

Sponsor

Valbiotis

Last update posted

Nov 26, 2024

Last verified

Nov, 2024

Keywords

  • MASLD
  • Cardiometabolic risk factors
  • Dietary supplement
  • Plant extracts
  • Polyphenols
  • Liver fat content
  • Magnetic Resonance Imaging
  • Overweight
  • Obesity
  • Glucose metabolism
  • Oral glucose tolerance test
  • Insulin sensitivity
  • Insulin secretion
  • Fibroscan
  • Health-related quality of Life
  • Body composition
  • Liver function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Valbiotis on 2024-11-26.