Effect of the Food Supplement TOTUM-070 on Lipid Metabolism

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Description

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).

Targeted Conditions

Study Overview

Start Date
October 4, 2023
Completion Date
April 30, 2025
Enrollment
180
Date Posted
February 6, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Biotesys
Esslingen 73728, Germany

Eligibility

Minimum Age (years)
18
Maximum Age (years)
70
Eligibility 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

Study Contact Info

Study Contact Name
Veronique Sapone, MSc; Annie Bouchard-Mercier, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed 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.
NCTid (if applicable)
NCT06243484