Black Garlic Nutraceuticals and Blood Pressure Control

Study Overview
=================
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.

Official Title
-----------------
Black Garlic Nutraceuticals Supplementation for the Control of Blood Pressure in Hypertension. A Triple-blind Randomized Placebo Control Study.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: ABG+ Black Garlin
* Dietary Supplement: Crystalline Cellulose


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three measurements, initial, middle, and final.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABG Black Garlic Extract<br>Daily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients. | Dietary Supplement: ABG+ Black Garlin<br>* Daily tablet intake during three months<br>|
| Placebo Comparator: Placebo<br>Daily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients | Dietary Supplement: Crystalline Cellulose<br>* Daily tablet intake during three months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure | Indirect measure of blood pressure by a trained physician | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Garlic, Nitric oxide, Angiotensin-converting enzyme, Antioxidant capacity, Endothelial function