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

NCT06704321 | Recruiting

• 1 other identifier: 2022-497
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Evolution of liver fat content

  Liver fat content measured by MRI

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

Secondary Outcomes (13)

• Evolution of lipid profile

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

• Evolution 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

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

• Evolution of inflammation

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

• Evolution of anthropometric variables

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

Study Arms (2)

TOTUM-448

EXPERIMENTAL

The experimental active arm will be supplemented with TOTUM-448 twice per day.

Dietary Supplement: TOTUM-448

Placebo

PLACEBO COMPARATOR

The placebo comparator arm will be supplemented with a placebo twice per day.

Dietary Supplement: Placebo

Interventions

TOTUM-448 DIETARY_SUPPLEMENT

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

TOTUM-448

Placebo DIETARY_SUPPLEMENT

16 weeks of placebo supplementation (8 capsules per day)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valbiotis: lead
• CHU de Quebec-Universite Laval: collaborator
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator
• Laval University: collaborator
• Valbiotis Canada inc.: collaborator

Study Sites (1)

Institut sur la nutrition et les aliments fonctionnels (INAF)

Québec, Quebec, G1V 0A6, Canada

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Overweight; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• André Marette, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Sapone, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, parallel, placebo-controlled study.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 26, 2024
• Study Start: January 31, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)