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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00131-42 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Excelya | INDUSTRY |
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This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTUM-854 | Experimental | Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes |
|
| Placebo | Placebo Comparator | Placebo comparator Seven capsules per day to consume orally in two intakes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOTUM-854 | Dietary Supplement | 12 weeks of TOTUM-854 supplementation |
| |
| 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 | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of Diastolic Blood Pressure |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Pałka, Dr | Centrum Medyczne Linden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiprofile Hospital for Active Treatment Cardiology Department | Haskovo | Bulgaria | ||||
| Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| Placebo |
| Dietary Supplement |
12 weeks of placebo supplementation |
|
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
| V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the fasting blood glycemia | Glycemia (in mg/dL), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the fasting blood concentration of triglycerides | Triglycerides (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the fasting blood concentration of total cholesterol | Total cholesterol (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the fasting blood concentration of HDL cholesterol | HDL cholesterol (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the fasting blood concentration of non-HDL cholesterol | non-HDL cholesterol (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method) | LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the fasting blood hsCRP concentration | hsCRP (in mg/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the body weight | Body weight (in kg), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the waist circumference | Waist circumference (in cm), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the hip circumference | Hip circumference (in cm), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Evolution of the cardiovascular disease risk (SCORE value) | Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Delay of occurence of pharmacological treatment requirement for hypertension 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 hypertension, TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
| Panagyurishte |
| Bulgaria |
| Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology | Plovdiv | Bulgaria |
| Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department | Plovdiv | Bulgaria |
| Diagnostic Consultative Center XX- Sofia EOOD | Sofia | Bulgaria |
| CHU Clermont Ferrand PIC/CIC Inserm 1405 | Clermont-Ferrand | France |
| Vitamed Gałaj i Cichomski sp.j | Bydgoszcz | Poland |
| Centrum Medyczne Linden | Krakow | Poland |
| Przychodnia Zespołu Lekarza Rodzinnego "Medyk" | Słupca | Poland |
| Centrum Medyczne Oporów | Wroclaw | Poland |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |