Hypertension
Conditions
Keywords
Garlic, Nitric oxide, Angiotensin-converting enzyme, Antioxidant capacity, Endothelial function
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTABG+ Black Garlin
Daily tablet intake during three months
DIETARY_SUPPLEMENTCrystalline Cellulose
Daily tablet intake during three months
Sponsors
Pharmactive, S.L.
Universitat de Lleida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Random number of samples
Intervention model description
Three measurements, initial, middle, and final.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
\- Clinical hypertension, medically treated with no more than 2 drugs
Exclusion criteria
* Body mass index above 35 kg/m2 * Fasting blood cholesterol levels below 115 mg/dL * Fasting blood glucose levels above 126 mg/dL * Taking anyone of the Angiotensin-converting enzyme inhibitors * Anemia (hemoglobin below 13 g/dL in men and below 12 g/dL in women) * Vitamin or nutraceutical intake in the last 30 days before the study enrollment * Chronic gastrointestinal diseases * Pregnancy and breastfeeding * Garlic allergy * Participation in another study 30 days before the study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | Baseline and 12 weeks | Indirect measure of blood pressure by a trained physician |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Angiotensin-converting enzyme activity | Baseline and 12 weeks | Activity measured by a substrate-enzyme activity kit |
| Change in Endothelial function | Baseline and 12 weeks | Endothelial blood flow capacity |
| Change in Blood nitric oxide content | Baseline and 12 weeks | Nitric oxide determined by nitrate and nitrite content in blood |
| Change in Blood cytokine profile | Baseline and 12 weeks | Analysis of cytokine profile (TNFa, IL-1b, IL-18, IL-6, IL-8, IL-17, IL-23, TGFb) in blood by immunoassays (Multiplexed) |
| Change in Blood antioxidant capacity | Baseline and 12 weeks | Reduction capacity of blood determined by a biochemistry assay |
| Change in Blood lipid profile | Baseline and 12 weeks | Analysis of lipid profile (Total-cholesterol, LDL-cholesterol, Triacylglycerides, HDL-Cholesterol) |
Countries
Spain
Contacts
Primary ContactMarcelino Bermúdez, PhD
Backup ContactJose S Serrano, PhD
Outcome results
None listed