Contribution of Dietary Cocoa Procyanidins to the Systemic Presence of Flavanols Metabolites in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Peak plasma concentration of flavanol metabolites
研究概览
简要总结
The purpose of this study is to determine whether or not the intake of dietary procyanidins (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.
详细描述
Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds normally present in the human diet. Accumulating data demonstrate a causal role for flavanols in mediating the cardiovascular benefits associated with the consumption of flavanol-/procyanidin-containing foods. Evidence for a direct, causal role for procyanidins in this context is far less profound. As this is often based on the poor absorption of procyanidins, it has been proposed that procyanidins may indirectly contribute to the systemic presence of bioactive compounds via derivatives generated from the breakdown or catabolism of procyanidins in the gastrointestinal tract. These postulated 'breakdown products' include: i) flavanols, putatively generated by acid hydrolysis in the stomach, and ii) series of phenolic compounds, including 5-(3,4-dihydroxyphenyl)-gamma-valerolactone, that are produced from procyanidin catabolism by the gut microbiome. Verification or rejection of these suppositions could significantly impact the interpretation of epidemiological-/dietary intervention data, and the design of food-content data bases. To address this question, healthy volunteers will consume specially designed cocoa-based dairy drinks containing flavanols and procyanidins (dimers to decamers) either together or individually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A normal blood chemistry and liver function
- •Fasting blood cholesterol and triglycerides < 300 mg/dl and < 3.0 mmol/l, respectively
- •BMI < 30 kg/m2 will be considered.
- •Volunteers must be able to read and speak English fluently, and thus, fully understand the researchers, research protocols, and their rights as a research volunteer.
排除标准
- •A history of cardiovascular disease, stroke, uncontrolled hypertension (> 160/90 mm), renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
- •A history of psychiatric illness or an allergy to peanuts.
结局指标
主要结局
Peak plasma concentration of flavanol metabolites
时间窗: After consumption at time points 0, 1, 2 and 4 h
The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.
Area under the curve described by the concentration of flavanol metabolites in plasma versus time
时间窗: After consumption at time points 0, 1, 2 and 4 h
The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.
次要结局
- Amount of flavanol metabolites excreted in urine(urine collected up to 24h post-consumption)
- Amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites in urine(urine collected up to 24 h post-consumption)