NCT03211767已完成不适用
Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- 24 hour ambulatory blood pressure
研究概览
简要总结
The primary objective of this trial is to assess the effect of consumption of aged garlic extract powder on 24 h systolic and diastolic ambulatory blood pressure in hypertensive individuals following 8 weeks of supplementation.
Additional secondary objectives are to assess the effects of aged garlic extract powder intake for 8 weeks on lipid profile (TC, HDL-C, LDL-C, and TG concentrations), blood glucose, office blood pressure, pulse-wave velocity and augmentation index, body mass index, and waist and hip circumference.
详细描述
Forty hypertensive volunteers between 18 and 75 years will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, double-blind, randomized, placebo-controlled intervention study for 8 weeks per study period following obtainment of informed consent.
The 2 periods of treatment will include:
- Treatment period: One capsule twice a day, providing 600 mg each of aged garlic extract powder, for a total of 1200 mg/day of aged garlic extract powder.
- Control period: The control product will be an identical-looking placebo capsules containing cellulose, which is being used as a filler in the treatment capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- 否
入选标准
- •Ability to give written informed consent.
- •Age: greater than or equal to 40 and less than or equal to 70 years.
- •Systolic blood pressure140-160mmHg and/or diastolic blood pressure 90-100 mmHg
- •LDL-C less than or equal to 4.9mmol/L
- •Those on a stable dose of blood pressure lowering or lipid-lowering medication for greater than or equal to 3 months; if a participant chooses to stop taking blood pressure lowering medications, they will be required to have a minimum 3 month washout period prior to commencement of the study; all other medications medications will be permitted if they are on a stable dose before the start of the study
- •Gender: Male and women who are not pregnant (determined by a negative urine pregnancy test at screening for women of childbearing potential) or lactating.
- •Language: Participants must be able to read, write and speak English.
排除标准
- •Systolic blood pressure > 160mmHg and/or diastolic blood pressure >100mmHg
- •Those currently taking (or have taken within the last 3 months) lipid-lowering or blood pressure-lowering supplements (i.e., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc.)
- •Patients with unstable or serious illness, for example, dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis.
- •History of cancer, chronic illness, cardiovascular problems, liver and kidney disease (including chronic kidney disease (GFR < 60ml/min/1.732)), diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological/psychological disease, bleeding disorders, experienced platelet abnormalities, macrovascular target organ damage (including cerebrovascular disease, stroke, hypertensive retinopathy, left ventricular dysfunction, angina pectoris, myocardial infarction, and peripheral artery disease)
- •History of taking any type of garlic preparation (i.e., dried garlic homogenate, aged garlic extract, processed garlic capsule, time-released garlic powder tablet, regular garlic pill, garlic powder and garlic oil) in the past 6 months. in the past 3 months. (Note: regular garlic clove consumption as part of prepared meals, cooking preparations, etc. are permitted throughout the study period)
- •Plan to consume any type of garlic preparation (i.e., dried garlic homogenate, aged garlic extract, processed garlic capsule, time-released garlic powder tablet, regular garlic pill, garlic powder and garlic oil. at any time during the study. (Note: regular garlic clove consumption as part of prepared meals, cooking preparations, etc. are permitted throughout the study period)
- •Have gained or lost greater than or equal to 10lbs in the previous 3 months, or plan to lose weight at any time during the study
- •Plan to become pregnant during the study period.
- •Women of childbearing potential not using effective contraception which include: Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; Intrauterine devices (IUD) or Intrauterine system (IUS); Tubal ligation; Vasectomy of partner; Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)
- •Consumption of more than 2 alcoholic drinks/day, or > 14 alcoholic beverages a week, or history of alcoholism or drug dependence.
- •History of allergy to garlic, microcrystalline cellulose, silicon dioxide, magnesium stearate, gelatin, hydroxypropylcellulose, or caramel coloring
- •Any planned surgeries any time during the study
- •Taking medications with psychotropic properties for less than 3 months, i.e., those taking medications with psychotropic properties, such as anti-depressants, anti-anxiety, etc., at a stable consistent dose for a minimum of 3 months are eligible for the study, as long as the medication is consumed at a stable, consistent dose throughout the study period
- •Exercising > 15 miles/wk or 4,000 kcal/wk
研究组 & 干预措施
Placebo
Placebo Comparator
2 capsules per day without aged garlic extract
干预措施: Placebo (Dietary Supplement)
Aged garlic extract
Active Comparator
2 capsules per day containing aged garlic extract
干预措施: Aged garlic extract (Dietary Supplement)
结局指标
主要结局
24 hour ambulatory blood pressure
时间窗: 8 weeks
次要结局
- Blood total cholesterol(8 weeks)
- Blood high-density lipoprotein cholesterol(8 weeks)
- Blood low-density lipoprotein cholesterol(8 weeks)
- Blood triglycerides(8 weeks)
- Pulse wave velocity(8 weeks)
- Office blood pressure(8 weeks)
- Hip circumference(8 weeks)
- Augmentation index(8 weeks)
- Body mass index(8 weeks)
- Waist circumference(8 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Aged Garlic Extract StudyMicrocirculationBiomarkersCoronary Artery DiseaseNCT03860350Lund University Hospital100
已完成
不适用
The Effect of Aged Garlic Extract Supplementation on Immune SystemImprovement in Immune Cell Function in Healthy HumansNCT01390116University of Florida120
已完成
不适用
The Effect of AGE on the Immune SystemHealthyNCT01959646University of Florida91
已完成
不适用
Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive ImpairmentMild Cognitive ImpairmentNCT06254040Biosearch S.A.110
撤回
2 期
Garlic in Hyperlipidemia Caused by HAARTHypercholesterolemiaHIV InfectionsHyperglycemiaHypertriglyceridemiaNCT00029250National Center for Complementary and Integrative Health (NCCIH)