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临床试验/NCT01780922
NCT01780922已完成不适用

Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action

Washington State University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年7月1日最近更新:
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
12
试验地点
1
主要终点
Interleukin-2 (IL-2) Concentrations in Plasma

研究概览

简要总结

The purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.

详细描述

Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol diet 2 days prior to the intervention. On the day of the study, baseline blood and urine samples will be collected after an overnight fast. Participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men & women; aged 18-35 years
  • •BMI: 19-25 kg/m2

排除标准

  • •Any significant chronic disease, hypertension, ulcers, dyspepsia, lactose intolerance, allergy, psychotic illness
  • •Had major gastrointestinal surgery or on prescription or surgical treatment
  • •Any condition that may interfere with the digestion, absorption, metabolism or excretion of nutrients
  • •Regularly smoked in the previous 6 months
  • •On medication or ingested a prescribed drug at any time within the 14 days preceding study enrolment (excluding hormonal contraceptives and hormone replacement therapy) or over-the-counter preparation within 7 days preceding enrolment
  • •Risk factors for AIDS or known HIV positive status
  • •Pregnant or lactating
  • •High intake of chocolate or similar high polyphenol foods
  • •Regular intake of vitamin and polyphenol supplements
  • •Drug and alcohol misuse
  • •Currently participating or had participated in another clinical study during the previous 3 weeks
  • •Donated blood in the previous 3 weeks
  • •Exercise more than 3 times/week for longer than 45 min each time

研究组 & 干预措施

Low Calorie Cranberry Juice Cocktail

Active Comparator

Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes

干预措施: Low Calorie Cranberry Juice Cocktail (Other)

Cranberry Extract Beverage

Active Comparator

Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes

干预措施: Cranberry Extract Beverage (Other)

Non-Cranberry Beverage

Placebo Comparator

Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes

干预措施: Non-Cranberry Beverage (Other)

结局指标

主要结局

Interleukin-2 (IL-2) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Interleukin-1beta (IL-1b) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Interferon-gamma (IFN-y) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Urinary Anti-bacteria Adhesion Activity

时间窗: 0, 3, 6, 9, 12, 24 h

Reduced Glutathione (GSH) Concentrations in Red Blood Cells

时间窗: 0, 2, 4, 8, 24 h

Superoxide Dismutase (SOD) Activity in Red Blood Cells

时间窗: 0, 2, 4, 8, 24 h

Glutathione Peroxidase (GPx) Activity in Red Blood Cells

时间窗: 0, 2, 4, 8, 24 h

Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)

时间窗: 0, 2, 4, 8, 24 h

C-Reactive Protein (CRP) Concentrations in Plamsa

时间窗: 0, 2, 4, 8, 24 h

Nitric Oxide (NO) Concentrations in Plamsa

时间窗: 0, 2, 4, 8, 24 h

Interleukin-1alpha (IL-1a) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Interleukin-4 (IL-4) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Interleukin-6 (IL-6) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Interleukin-8 (IL-8) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

Interleukin-10 (IL-10) Concentrations in Plasma

时间窗: 0, 2, 4, 8, 24 h

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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