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| ID | Type | Description | Link |
|---|---|---|---|
| BTS1815/21 | Other Identifier | Biotesys |
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| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
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The main objective of the study will be to compare the efficacy of a 2.65 g/day dose of TOTUM-854 versus placebo in decreasing SBP in subjects with high-normal blood pressure and Grade I hypertension following 12 weeks of daily intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Totum-854 | Experimental | 2.65-g dose of Totum-854 dietary supplement, a mix of 6 plant extracts. Five capsules per day to consume orally in two intakes Other names: active product |
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| Placebo | Placebo Comparator | Five capsules per day to consume orally in two intakes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Totum-854 | Dietary Supplement | To compare Totum-854 with Placebo on blood pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure at V4 | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo | V4 (12 weeks of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of Systolic Blood Pressure | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of Diastolic Blood Pressure |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronique SAPONE | Contact | +33 5 17 06 84 80 | veronique.sapone@valbiotis.com | |
| Maxime Bargetto | Contact | +33 5 17 06 84 80 |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Menzel, MD | BioTeSys GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys | Recruiting | Esslingen am Neckar | 73728 | Germany |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Dietary Supplement | Five capsules per day to consume orally in two intakes |
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Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
| V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of fasting blood glycemia | Glycemia (in mg/dL), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of the fasting blood concentration of triglycerides | Triglycerides (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of the fasting blood concentration of total cholesterol | Total cholesterol (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of the fasting blood concentration of HDL cholesterol | HDL cholesterol (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of the fasting blood concentration of non-HDL cholesterol | non-HDL cholesterol (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of the fasting blood concentration of LDL cholesterol | LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of fasting blood concentration of hsCRP | hsCRP (in mg/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of body weight | Body weight (in kg), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of waist circumference | Waist circumference (in cm), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of hip circumference | Hip circumference (in cm), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of waist hip Ratio | Waist Hip Ratio, TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Evolution of cardiovascular disease risk | Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |
| Delay of occurence of pharmacological treatment requirement for hypertension from V1 | Dealy 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 hypertension, TOTUM-854 vs placebo | V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) |