Effects of Oligonol on Vascular Function and Inflammation in Healthy Men: A Double-Blind, Dose-Finding Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Peripheral Arterial Tonometry
研究概览
简要总结
The investigators hypothesize that acute consumption of Oligonol, a patented lychee fruit extract (Amino Up Chemical Co.) particularly rich in low molecular weight flavanols, will improve endothelial function, reduce platelet reactivity and increase circulating levels of flavonoids after a single intake.
详细描述
The investigators have demonstrated from previous studies at UC Davis that a single dose of a high-flavanol supplement from cocoa can improve endothelial function, measured by increased blood flow from peripheral arterial tonometry (PAT), reduce platelet reactivity, and increase circulating levels of flavonoids in the blood. The investigators seek with this proposal to determine if a similar response can be noted with a different high-flavanol supplement in normal, healthy people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 yrs.
- •Healthy, not taking prescription medications
- •Subject is willing and able to comply with the study protocols.
- •Subject is willing to consume the Oligonol extract drink or placebo once a week for each of three weeks.
排除标准
- •Physical signs of health impairment.
- •Abnormal clinical laboratory (CBC, chemistry, liver, etc.) values if determined to be clinically significant by Dr. Eric Gershwin
- •Inflammatory disorders (e.g. rheumatoid arthritis)
- •Malabsorption
- •Treatment with corticosteroids, hypolipidemic and anti-inflammatory drugs
- •Renal or Liver disease
- •Heart Disease, which includes cardiovascular events and stroke
- •Cushing's syndrome
- •History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year.
- •Anti-anxiety medications
- •Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, ACE-inhibitors, and beta-blockers, erectile dysfunction drugs.
- •Asthma (can be worsened by mild to moderate food allergies).
- •Indications of substance or alcohol abuse within the last 3 years
- •Undergoing nicotine cessation therapy
- •Multi-Vitamin and mineral use other than a One-A-Day type formula
- •Current, consistent use of herbal or plant-based supplements; omega-3 fatty acids, and fish or unwilling to discontinue use while participating in the study.
- •Alcohol consumption > 1 oz/day (2 beers/day or 2 glasses of wine/ day, 1 drink of hard liquor/day)
- •Chronic high-intensity exercise
研究组 & 干预措施
100 mg of Oligonol
干预措施: Oligonol (Dietary Supplement)
200 mg of Oligonol
干预措施: Oligonol (Dietary Supplement)
0 mg of Oligonol
干预措施: Oligonol (Dietary Supplement)
结局指标
主要结局
Peripheral Arterial Tonometry
时间窗: 0 and 2 hours
次要结局
未报告次要终点