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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02809-30 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Biofortis Mérieux NutriSciences | OTHER |
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This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070, daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol concentration (determined by ultracentrifugation method) after 24 weeks of consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTUM-070 | Experimental | Experimental active diet supplement TOTUM-070 taken 2 times per day |
|
| Placebo | Placebo Comparator | Placebo comparator taken 2 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOTUM-070 | Dietary Supplement | 5-g dose of TOTUM-070 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood LDL cholesterol concentration at V3 with ultracentrifugation method | Fasting blood LDL concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo | V3 (24 weeks of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the fasting blood LDL cholesterol concentration with ultracentrifugation method | Fasting blood LDL cholesterol concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo | V1 (baseline) and V2 (12 weeks of intervention) |
| Evolution of the fasting blood concentration of triglycerides |
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Inclusion Criteria:
At V0 biological analysis, the subjects will be eligible to the study on the following criteria:
Exclusion Criteria:
At V0 biological analysis, the subjects will be considered as non-eligible to the study on the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Metreau, MD | Biofortis Mérieux NutriSciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Pasteur de Lille | Lille | 59019 | France | |||
| Unité d'Investigation Clinique Biofortis Mérieux NutriSciences |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| D050177 | Overweight |
| D009765 | Obesity |
| D050197 | Atherosclerosis |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
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2 blinded arms (Active and Placebo)
| Placebo | Dietary Supplement | Placebo. Eight capsules per day to consume orally in two intakes |
|
|
Triglycerides (in g/L), TOTUM-070 vs placebo |
| V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood concentration of total cholesterol | Total cholesterol (in g/L), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood concentration of HDL cholesterol | HDL cholesterol (in g/L), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood concentration of non-HDL cholesterol | non-HDL cholesterol (in g/L), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method) | LDL cholesterol (in g/L, Friedewald method), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood concentration of free fatty acids | Free fatty acids (in g/L), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood glycemia | Glycemia (in mg/dL), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood hsCRP concentration | hsCRP (in mg/L), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood concentration of apolipoprotein-A1 | Apolipoprotein-A1 (in g/L), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the fasting blood concentration of apolipoprotein-B | Apolipoprotein-B (in g/L), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of atherogenic index | Atherogenic index, TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of atherogenic coefficient | Atherogenic coefficient, TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of Cardiac risk ratio 1 | Cardiac risk ratio 1, TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of Cardiac risk ratio 2 | Cardiac risk ratio 2, TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of Apo-B/Apo-A1 ratio | Apo-B/Apo-A1 ratio, TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the body weight | Body weight (in kg), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the waist circumference | Waist circumference (in cm), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the hip circumference | Hip circumference (in cm), TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the waist to hip ratio | Waist to hip ratio, TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Delay of occurence of pharmacological treatment requirement for hypercholesterolemia from V1 | Delay between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his hypercholesterolemia, TOTUM-070 vs placebo | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Evolution of the cardiovascular disease risk (SCORE value) | Systematic Coronary Risk Estimation value from Heartscore calculator | V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention) |
| Paris |
| 75012 |
| France |
| Biofortis Mérieux NutriSciences | Saint-Herblain | 44800 | France |
| Biotesys | Esslingen am Neckar | 73728 | Germany |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |