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

Valbiotis

Status: Enrolling

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: TOTUM-448

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06704321

2022-497

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

TOTUM-448

Experimental group

Description:

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

Treatment:

Dietary Supplement: TOTUM-448

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo