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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01474-39 | Other Identifier | ID-RCB |
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The recruitment period has come to an end and will not be renewed due to insufficient recruitment.
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| Name | Class |
|---|---|
| University Hospital, Clermont-Ferrand | OTHER |
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This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTUM-070 | Experimental | Experimental active diet supplement TOTUM-070 taken 2 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOTUM-070 | Dietary Supplement | 2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of blood LDL cholesterol concentration at 6 weeks | LDL cholesterol (Friedewald method) | V1 (baseline) and V2 (6 weeks of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the fasting blood concentration of triglycerides | Triglycerides | V1 (baseline) and V2 (6 weeks of intervention) |
| Change from baseline of the fasting blood concentration of total cholesterol |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Clermont Ferrand | Clermont-Ferrand | 63000 | France |
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Total cholesterol
| V1 (baseline) and V2 (6 weeks of intervention) |
| Change from baseline of the fasting blood concentration of HDL cholesterol | HDL cholesterol | V1 (baseline) and V2 (6 weeks of intervention) |
| Change from baseline of the fasting blood concentration of non-HDL cholesterol | Non-HDL cholesterol | V1 (baseline) and V2 (6 weeks of intervention) |
| Change from baseline of the fasting blood concentration of free fatty acids | Free fatty acids | V1 (baseline) and V2 (6 weeks of intervention) |
| Change from baseline of the fasting blood concentration of apolipoprotein-A1 | Apolipoprotein-A1 | V1 (baseline) and V2 (6 weeks of intervention) |
| Change from baseline of the fasting blood concentration of apolipoprotein-B | Apolipoprotein-B | V1 (baseline) and V2 (6 weeks of intervention) |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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