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

November 22, 2024 updated by: Valbiotis

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Recruiting
        • Institut sur la nutrition et les aliments fonctionnels (INAF)
        • Contact:
        • Contact:
          • Patrick Couture, MD FRCP PhD
        • Contact:
          • Marie-Claude Vohl, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TOTUM-448
The experimental active arm will be supplemented with TOTUM-448 twice per day.
Dietary supplement: TOTUM-448
16 weeks of TOTUM-448 supplementation (4.284g/day corresponding to 8 capsules per day)
Placebo Comparator: Placebo
The placebo comparator arm will be supplemented with a placebo twice per day.
Dietary supplement: Placebo
16 weeks of placebo supplementation (8 capsules per day)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evolution of liver fat content
Time Frame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)
Liver fat content measured by MRI
Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution of lipid profile
Time Frame: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
Measurement of standard lipid profile
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)
Measurement of glucose homeostasis
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)
Cap score assessed by Fibroscan
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)
Measurement of hs-CRP in mg /L Measurement of IL-6, MCP-1, RANTES in pg/ml
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)
Measurement of BMI in kg/m²
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 body composition (i.e. total and trunk fat mass, total and trunk lean body mass) measured by Dual Energy X-ray Absorptiometry (DEXA)
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)
Health-related quality of life (HRQoF) assessed by Medical Outcome Study Short Form - 36 (MOS SF-36), a generic tool to measure and compare the HRQoL on study population.
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)
Measurement of liver assessment
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)
Measurement of kidney assessment
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)
Measurement of systolic and diastolic blood pressure in mmHg
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)
Measurement of white blood cells, red blood cells, number of platelets, amount of hemoglobin in the blood, hematocrit, mean red blood volume, mean hemoglobin amount per red blood cell, mean amount of hemoglobin relative to the size of the cell per red blood cell
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)
Measurement of thyroid stimulating hormone
Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
Evolution of adverse events (TEAE, STEAE, TEAE leading to investigational product discontinuation, TEAR)
Time Frame: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)
Treatment-Emergent Adverse Events (TEAE), Serious-TEAE (STEAE), TEAE leading to investigational product discontinuation, Treatment-Emergent Adverse Reaction (TEAR)
Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Valbiotis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CHU de Quebec-Universite Laval
Laval University
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Valbiotis Canada inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: André Marette, PhD, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-497

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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