Grape Polyphenol Kinetics in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Plasma polyphenols
研究概览
简要总结
The objectives of this study are the following: 1) to confirm that the administration of grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined administration of grape juice, resveratrol, and grape seed polyphenol extract result in a similar plasma and urinary metabolic profile in adults with tendencies toward metabolic syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol extract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Age <60 years at beginning of study
- •Fasting glucose > 126 mg/dl
- •Blood pressure > 160/100
- •Fasting total blood cholesterol > 280 mg/dl
- •Fasting triglycerides > 300 mg/dl
- •Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- •Presence of type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- •History of bariatric or certain other surgeries related to weight control
- •Smokers or other tobacco users (during 6 months prior to the start of the study)
- •Consumption of more than 3 servings of tea, wine, or grape juice per day
- •Use of supplements containing grape extracts or products
- •Use of antibiotics during the intervention or for 3 weeks prior to the intervention period
- •History of eating disorders, dietary patterns, or supplement use which will interfere with the goal of the intervention
- •Volunteers who have lost 10% of body weight within the last 4 months
- •Volunteers who are unable or unwilling to give informed consent or communicate with study staff
- •Volunteers who self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
研究组 & 干预措施
Grape
干预措施: Grape (Other)
结局指标
主要结局
Plasma polyphenols
时间窗: 6 hours
Blood will be analyzed for polyphenols and polyphenol metabolites.
Urinary polyphenols
时间窗: 6 hours
Urine will be analyzed for polyphenols and polyphenol metabolites.
次要结局
未报告次要终点
研究者
Janet Novotny
Principal Investigator
USDA Beltsville Human Nutrition Research Center