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

Clinical Study to Investigate the Effect of the Food Supplement TOTUM-070 on Lipid Metabolism in Moderately Hypercholesterolemic Subjects After 3 Months of Supplementation

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).

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: TOTUM-070; Dietary supplement: PLACEBO

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronique Sapone, MSc; Phone Number: +33546286258; Email: veronique.sapone@valbiotis.com
• Study Contact Backup: Name: Annie Bouchard-Mercier, PhD; Email: annie.bouchard@valbiotis.com

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • Recruiting
    • Biotesys
    • Principal Investigator: Daniel Menzel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PLACEBO; The placebo comparator arm will be supplemented with a placebo twice a day	Dietary supplement: PLACEBO; 8 capsules per day to consume orally in two intakes; Other Names: Comparator product 2 intakes per day
Experimental: TOTUM-070; The experimental arm will be supplemented with TOTUM-070 twice a day	Dietary supplement: TOTUM-070; 12 weeks of TOTUM-070 supplementation with Placebo (blinded arms); Other Names: Active product 2 intakes per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of fasting blood LDL cholesterol level	Fasting blood LDL cholesterol level by Ultracentrifugation method	Baseline (V1) and End of consumption after 12 weeks (V3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of fasting blood LDL cholesterol level	Fasting blood LDL cholesterol level by Ultracentrifugation method	Baseline (V1), Following 6 weeks of consumption (V2) and 6 weeks after the end of consumption (V4)
Evolution of Lipid profile	Triglycerides, Total-cholesterol, HDL-C, non-HDL-C, LDL-C, Free Fatty Acids, Apo-A1 and Apo-B, Apo-B/Apo-A1 ratio, Apo-C3	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of Lipid homeostasis indices	Atherogenic index (ratio of triglycérides and HDL-C), atherogenic coefficient (ratio of total-cholesterol and HDL-C), cardiac risk ratio 1 (ratio of total-cholesterol and HDL-C), cardiac risk ratio 2 (ratio of LDL-C and HDL-C) (note that all these measures are unitless ratios)	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of fasting glycemia	Fasting Glycemia (in mg/dL)	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of Low grade inflammation	Fasting blood hsCRP, Interleukin-6	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of body weight	Body weight (BW) in kg	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of waist circumference	Waist circumference (WC) in cm	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of hip circumference	Hip circumference (HC) in cm	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of waist to hip ratio	Waist to hip ratio (WHR)	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of body mass index	Body mass index (BMI) in kg/m2	Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)

Collaborators and Investigators

• Sponsor: Valbiotis
• Investigators: Principal Investigator: Daniel Menzel, MD, Biotesys

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: VCT-013; BTS1876_22 (Other Identifier: Biotesys)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No