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| ID | Type | Description | Link |
|---|---|---|---|
| BTS1876_22 | Other Identifier | Biotesys |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTUM-070 | Experimental | The experimental arm will be supplemented with TOTUM-070 twice a day |
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| PLACEBO | Placebo Comparator | The placebo comparator arm will be supplemented with a placebo twice a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOTUM-070 | Dietary Supplement | 12 weeks of TOTUM-070 supplementation with Placebo (blinded arms) |
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| 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) |
| 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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Menzel, MD | Biotesys | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotesys | Esslingen am Neckar | 73728 | Germany |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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A MULTICENTER, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLINDED STUDY
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The study will be conducted in a double-blind randomized manner. The random allocation sequence will be provided sealed to the independent pharmacist (not involved in the study) by an independent statistician. The ratio of randomization between the verum and placebo groups will be 1:1. Stratification randomization will be performed according to LDL-c at V0 (<160 mg/dL / ≥ 160 mg/dL) and site.
| PLACEBO | Dietary Supplement | 8 capsules per day to consume orally in two intakes |
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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 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) |
| 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) |
| D009750 |
| Nutritional and Metabolic Diseases |