Effect of the Food Supplement TOTUM-070 on Lipid Metabolism

Hypercholesterolemia Clinical Trial

— HEARTII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243484
• Other study ID #: VCT-013
• Secondary ID: BTS1876_22
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Valbiotis
• Contact: Veronique Sapone, MSc
• Phone: +33546286258
• Email: veronique.sapone[@]valbiotis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• TOTUM-070
12 weeks of TOTUM-070 supplementation with Placebo (blinded arms)
• PLACEBO
8 capsules per day to consume orally in two intakes

Locations

Country	Name	City	State
Germany	Biotesys	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Valbiotis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)