Effect of the Food Supplement TOTUM-070 on Lipid Metabolism (HEARTII)

Valbiotis

Status: Active, not recruiting

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: PLACEBO; Dietary Supplement: TOTUM-070

Study type: Interventional

Funder types: Industry

Identifiers

NCT06243484

BTS1876_22 (Other Identifier)

VCT-013

Details and patient eligibility

About

This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).

Full description

The main objective is to confirm the efficacy of a 4.995g/day dose of TOTUM-070 versus placebo on fasting blood LDL cholesterol level (Ultracentrifugation (UC) method) in moderately hypercholesterolemic subjects following 12 weeks of consumption (V3).

The proposed double-blinded, placebo-controlled, clinical study will provide further insight into the safety and efficacy of TOTUM-070 at the same dose (4.995g/day) on a shorter supplementation period (3 months) than the previous one (6 months), as well as assess the effect after the follow-up period without product intake.

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• I1. From 18 to 70 years (including ranges);
• I2. BMI of ≥18.5 and ≤35 kg/m²;
• I3. Moderately hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain...) and not requiring immediate pharmacological lipid-lowering treatment;
• I4. Weight stable within ± 5% in the last three months before V0;
• I5. SCORE2 - SCORE2-OP (Older Persons) Cardiovascular Risk Chart

Main Exclusion Criteria:

• E1. Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations;
• E2. Suffering from an uncontrolled arterial hypertension;
• E3. With a history of ischemic cardiovascular event;
• E4. Having undergone recent surgical procedure in the past 6 months before V0 or planned in the 5 months to come;
• E5. History of bariatric surgery;
• E6. Suffering from a severe chronic disease;
• E7. For women: ongoing pregnancy (as evidenced by a positive test for β-Human Chorionic Gonadotropin, i.e. > 5 mUI/mL, realized at V0) or breastfeeding or finished since less than 6 months before V0 or intending to become pregnant within 5 months ahead;
• E8. Under cholesterol and/or lipid-lowering treatment or stopped less than 3 months before the inclusion visit V0;
• E9. Under medication which could affect blood lipid parameters or stopped less than 3 months before the inclusion visit V0 (antihypertensive stable long-term treatment tolerated);
• E10. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

TOTUM-070

Experimental group

Description:

The experimental arm will be supplemented with TOTUM-070 twice a day

Treatment:

Dietary Supplement: TOTUM-070

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: PLACEBO