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| Name | Class |
|---|---|
| Pharmactive Biotech Products S.L.U | INDUSTRY |
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Black garlic contains a series of allyl-sulfur compounds with the ability to modulate nitric oxide synthetase, angiotensin-converting enzyme system, and endothelial activation, which together could help better control blood pressure. The main objective of this study is to evaluate the effect on blood pressure and endothelial health of a daily intake of a black garlic supplement named ABG (registered mark), which has a higher concentration of black garlic bioactive compounds, in people with moderate hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABG Black Garlic Extract | Experimental | Daily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients. |
|
| Placebo | Placebo Comparator | Daily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABG+ Black Garlin | Dietary Supplement | Daily tablet intake during three months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Indirect measure of blood pressure by a trained physician | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood nitric oxide content | Nitric oxide determined by nitrate and nitrite content in blood | Baseline and 12 weeks |
| Change in Angiotensin-converting enzyme activity | Activity measured by a substrate-enzyme activity kit |
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Inclusion Criteria:
- Clinical hypertension, medically treated with no more than 2 drugs
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelino Bermúdez, PhD | Contact | +34 973702482 | mbermudez@irblleida.cat | |
| Jose S Serrano, PhD | Contact | +34 973702408 | josecarlos.serrano@udl.cat |
| Name | Affiliation | Role |
|---|---|---|
| Manuel S Portero, PhD | Universitat de Lleida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arnau de Vilanova | Recruiting | Lleida | 25198 | Spain |
IPD data will not be shared.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Three measurements, initial, middle, and final.
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Random number of samples
| Crystalline Cellulose |
| Dietary Supplement |
Daily tablet intake during three months |
|
| Baseline and 12 weeks |
| Change in Endothelial function | Endothelial blood flow capacity | Baseline and 12 weeks |
| Change in Blood lipid profile | Analysis of lipid profile (Total-cholesterol, LDL-cholesterol, Triacylglycerides, HDL-Cholesterol) | Baseline and 12 weeks |
| Change in Blood cytokine profile | Analysis of cytokine profile (TNFa, IL-1b, IL-18, IL-6, IL-8, IL-17, IL-23, TGFb) in blood by immunoassays (Multiplexed) | Baseline and 12 weeks |
| Change in Blood antioxidant capacity | Reduction capacity of blood determined by a biochemistry assay | Baseline and 12 weeks |