Black Garlic Nutraceuticals Supplementation for the Control of Blood Pressure in Hypertension. A Triple-blind Randomized Placebo Control Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Random number of samples
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical hypertension, medically treated with no more than 2 drugs
排除标准
- •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
研究组 & 干预措施
ABG Black Garlic Extract
Daily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients.
干预措施: ABG+ Black Garlin (Dietary Supplement)
Placebo
Daily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients
干预措施: Crystalline Cellulose (Dietary Supplement)
结局指标
主要结局
Change in Blood Pressure
时间窗: Baseline and 12 weeks
Indirect measure of blood pressure by a trained physician
次要结局
- Change in Blood antioxidant capacity(Baseline and 12 weeks)
- Change in Blood nitric oxide content(Baseline and 12 weeks)
- Change in Angiotensin-converting enzyme activity(Baseline and 12 weeks)
- Change in Endothelial function(Baseline and 12 weeks)
- Change in Blood lipid profile(Baseline and 12 weeks)
- Change in Blood cytokine profile(Baseline and 12 weeks)
研究者
José Serrano
Principal Investigator
Universitat de Lleida