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Non-Alcoholic Fatty Liver DiseaseCARDIO-LIVERNCT06704321

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

A study testing TOTUM-448 in people with Non-Alcoholic Fatty Liver Disease, run by Valbiotis at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
What is being tested?
TOTUM-448
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteCanada
Study dates
31 Jan 2024to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Véronique Sapone, MSc contact

+33 (0)6 75 32 66 59

veronique.sapone@valbiotis.com

Canada1 site, 1 recruiting

  • Institut sur la nutrition et les aliments fonctionnels (INAF)

    Québec, Quebec, G1V 0A6

    Julie Marois, MSc, +1 (418) 656-2131 ext. 405764, julie.marois@fsaa.ulaval.ca

    Patrick Couture, MD FRCP PhD

    Recruiting

Other trials in Canada

About this study

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

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.

Being tested
TOTUM-448, Placebo
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
Medical subject headings
Non-alcoholic Fatty Liver Disease, Overweight, Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOTUM-448Dietary supplement

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

  • PlaceboDietary supplement

    16 weeks of placebo supplementation (8 capsules per day)

Study groups in NCT06704321
Study groupRoleWhat they receive
TOTUM-448ExperimentalThe experimental active arm will be supplemented with TOTUM-448 twice per day.
Receives: Dietary Supplement: TOTUM-448
PlaceboPlacebo comparatorThe placebo comparator arm will be supplemented with a placebo twice per day.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evolution of liver fat content

    Liver fat content measured by MRI

    Measured: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)

Secondary outcomes (13)

  1. Evolution of lipid profile

    Measurement of standard lipid profile

    Measured: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  2. Evolution of glucose homeostasis

    Measurement of glucose homeostasis

    Measured: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  3. Evolution of liver health

    Cap score assessed by Fibroscan

    Measured: Screening (V0), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  4. Evolution of inflammation

    Measurement of hs-CRP in mg /L Measurement of IL-6, MCP-1, RANTES in pg/ml

    Measured: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  5. Evolution of anthropometric variables

    Measurement of BMI in kg/m²

    Measured: Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  6. Evolution of body composition

    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)

    Measured: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)

  7. Evolution of health-related quality of life

    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.

    Measured: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)

  8. Evolution of hepatic function

    Measurement of liver assessment

    Measured: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  9. Evolution of kidney function

    Measurement of kidney assessment

    Measured: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  10. Evolution of hemodynamic measurements

    Measurement of systolic and diastolic blood pressure in mmHg

    Measured: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  11. Evolution of complete blood count

    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

    Measured: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  12. Evolution of thyroid stimulating hormone

    Measurement of thyroid stimulating hormone

    Measured: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

  13. Evolution of adverse events (TEAE, STEAE, TEAE leading to investigational product discontinuation, TEAR)

    Treatment-Emergent Adverse Events (TEAE), Serious-TEAE (STEAE), TEAE leading to investigational product discontinuation, Treatment-Emergent Adverse Reaction (TEAR)

    Measured: Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start31 Jan 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blinded, parallel, placebo-controlled study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06704321
Sponsor's protocol ID
2022-497
Acronym
CARDIO-LIVER
Status last verified
Nov 2024
First submitted
12 Nov 2024
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TOTUM-448 in people with Non-Alcoholic Fatty Liver Disease, run by Valbiotis at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Véronique Sapone, MSc (+33 (0)6 75 32 66 59, veronique.sapone@valbiotis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of liver fat content (time frame: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06704321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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