NCT05138939已完成不适用
Effects of Japanese Red Wines on Vascular Function in Adult Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Peripheral Arterial Tonometry (PAT)
研究概览
简要总结
The overall objective of this study is to investigate the effects of different types of red wine on markers of endothelial function and platelet aggregation.
详细描述
Potential participants are provided with information about the study and potential risks. Once participants decided to participate in the study, they will be scheduled for a health screening visit which determines eligibility to the study entry. If participants are eligible, they will be randomized in a three-way crossover study design to receive three interventions (control, red wine1, and red wine2) with the one-week washout period. On the study day, participants will be assessed for baseline measurements, provided with the designated beverage, and followed up for the measurements at 2 and 4 hours after the consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded by the type of beverages (control, red wine1, and red wine2).
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male: 50-70 years old
- •Subject is willing and able to comply with the study protocols.
- •Subject is willing to participate in all study procedures
- •BMI 18.5 - 40 kg/m2
- •Weight ≥ 110 pounds
- •Prescription medication if on a 6-month self-reported stable dose
- •Regularly consume alcoholic beverages (2 drinks/week to 2 drinks/day)
- •Non-smokers
- •One standard drink of alcoholic beverages is defined as follow:
- •12-ounces of beer (5% alcohol content) (~1 regular bottle). 8-ounces of malt liquor (7% alcohol content) (~1 regular bottle). 5-ounces of wine (12% alcohol content) (~½ glass) 1.5-ounces of 80-proof (40% alcohol content) distilled spirits or liquor (e.g., gin, rum, vodka, whiskey) (~ 1 shot)
排除标准
- •BMI ≥ 40 kg/m2
- •Daily use of aspirin or NSAIDs
- •Dislike or allergic to any food, especially wine, grape, and alcohol
- •Vegan, Vegetarians, food faddists, or those consuming a non-traditional diet
- •Alcohol consumption < 2 drinks/week (i.e. 1 bottle of beer, ½ glass of wine, and 1 shot of hard liquor)
- •Alcohol consumption > 2 drinks/ day
- •Fruit consumption ≥ 2 cups/day
- •Vegetable consumption ≥ 3 cups/day
- •Fatty Fish ≥ 3 times/week
- •Coffee/tea ≥ 3 cups/day
- •Dark chocolate ≥ 3 oz/day
- •Self-reported restriction of physical activity due to a chronic health condition
- •Self-reported chronic/routine high intensity exercise
- •Self-reported diabetes
- •Blood pressure ≥ 140/90 mm Hg
- •Self-reported renal or liver disease
- •Self-reported heart disease, which includes cardiovascular events and Stroke
- •Self-reported Cushing's syndrome
- •Self-reported chronic/routine high-intensity exercise
- •Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
- •Abnormal Liver or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
- •Self-reported cancer within the past 5 years
- •Self-reported malabsorption
- •Use of multi-vitamin and minerals other than a general formula of vitamins and minerals that meet the recommended dietary allowance (RDA)
- •Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
- •Indications of substance or alcohol abuse within the last 3 years
- •Current enrollee in a clinical research study.
- •Reactive hyperemia index (RHI) value ≥ 2.8 (measured by PAT at the first study visit)
- •Raynaud's disease, history of bleeding disorder and/or abnormal bleeding, and history of gastrointestinal ulceration and/or bleeding
- •Under current medical supervision
- •1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of < 65%.
- •Platelet number or mean platelet values that are outside of the normal reference range as indicated on a complete blood cell count report from the University of California Davis Medical Center
- •Current diagnosis of anemia; or a screening hemoglobin and hematocrit that is less than the normal reference range.Individuals with blood clotting or platelet defect disorders
- •The following special populations will be excluded:
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Peripheral Arterial Tonometry (PAT)
时间窗: 4 hours after beverage consumption
Endothelial function
次要结局
- Platelet Aggregation(Baseline and 2 and 4 hours after beverage consumption)
研究者
研究点 (2)
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