Clinical trial NCT06243484: Effect of the Food Supplement TOTUM-070 on Lipid Metabolism
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A MULTICENTER, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLINDED STUDY
Primary purpose: PREVENTION

Brief 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).

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.

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

Primary outcomes:
measure: Evolution of fasting blood LDL cholesterol level
timeFrame: Baseline (V1) and End of consumption after 12 weeks (V3)
Secondary outcomes:
measure: Evolution of fasting blood LDL cholesterol level
timeFrame: Baseline (V1), Following 6 weeks of consumption (V2) and 6 weeks after the end of consumption (V4)
measure: Evolution of Lipid profile
timeFrame: 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)
measure: Evolution of Lipid homeostasis indices
timeFrame: 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)
measure: Evolution of fasting glycemia
timeFrame: 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)
measure: Evolution of Low grade inflammation
timeFrame: 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)
measure: Evolution of body weight
timeFrame: 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)
measure: Evolution of body mass index
timeFrame: 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)
measure: Evolution of waist circumference
timeFrame: 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)
measure: Evolution of hip circumference
timeFrame: 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)
measure: Evolution of waist to hip ratio
timeFrame: 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)
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Biotesys
Study officials:
affiliation: Biotesys
name: Daniel Menzel, MD
role: PRINCIPAL_INVESTIGATOR
References: