NCT06264622Unknown不适用
Dose Response Study of the Effects of a Daily Supplementation With a Black Garlic Extract, ABG+/GarlACE on Cardiovascular Disease Risk Factors in Subjects With Grade I Hypertension
Universitat de Lleida2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年2月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:
- If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
- If the changes in lipid profile are in a dose-response manner
Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with Grade I Hypertension (systolic blood pressure between 130 and 139 mmHg; and diastolic blood pressure between 80 to 89 mmHg) without taking any antihypertensive drug
排除标准
- •Acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- -
- •Hypothyroidism
- •Having previously suffered a myocardial infarction or stroke
- •Pharmacological treatment with insulin, sulfonylureas, protease inhibitors
- •Chronic gastrointestinal disease
- •Pregnancy or intention to become pregnant during the study period.
- •Breastfeeding
- •Allergy or intolerance to garlic
- •High alcohol consumption (>14 units per week)
研究组 & 干预措施
Low Dose
Experimental
250 mg/day of Garlic Extract
干预措施: Low dose (Dietary Supplement)
High Dose
Experimental
600 mg/day of Garlic Extract
干预措施: High dose (Dietary Supplement)
Placebo
Placebo Comparator
Placebo tablets
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Blood Pressure
时间窗: Pre-treatment and 12 weeks post-treatment
Upper arm blood pressure (Systolic and Diastolic)
次要结局
- Blood Lipid Profile(Pre-treatment and 12 weeks post-treatment)
研究者
José Serrano
Professor
Universitat de Lleida
研究点 (2)
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