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临床试验/NCT02587468
NCT02587468已完成不适用

Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+®)

Green Beat4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年10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
发起方
入组人数
20
试验地点
4
主要终点
Absorption kinetics of phenolic acids after 1, 2, 5 and 10 hours, measured via HPLC, evaluated by repeated measures ANOVA, and assessed via SPSS 19.0.

研究概览

简要总结

GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder

ENDPOINTS

  • Absorption kinetics of phenolic compounds in plasma
  • Bioavailability of vitamins C, E, and carotenoids into plasma

Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).

详细描述

Phytonutrients are regarded to play an important role in many health-related issues like:

  • Improvement of redox balance
  • Anti-inflammatory effects
  • Prevention of chronic diseases like CVD, stroke, diabetes II, Alzheimer´s, AMD, and certain forms of cancer
  • Beneficial effects on human´s microbiome Therefore it is of scientific interest whether this product provides absorbable phytonutrients/phenolics and vitamins to support mechanistic explanations for the beneficial outcomes observed in the past after intake of Juice Plus+®.

GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder

MERITS

  • This study would reveal knowledge whether and to which extent specific vitamins and phenolic compounds are absorbed, including absorption kinetics/metabolism.
  • Data of this study may provide support for mechanistic arguments on the beneficial clinical outcomes observed and published in the past.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20 healthy men and women, 20-50 years old;
  • non-smokers;
  • BMI >20 und <30 kg/m2;
  • no medication;
  • premenopausal;
  • normal dietary habits (no specific diets, meals, food components etc.);
  • adherence to wash-out period.

排除标准

  • all people not meeting the inclusion criterions;
  • diet: subjects consuming >4 servings of fruits and vegetables per day;
  • subjects with any kind of food allergy or histamine intolerance;
  • highly trained subjects (> 5 training units/week);
  • women with menstrual dysfunctions;
  • pregnancy
  • alcoholics.

研究组 & 干预措施

Juice Plus+(R)

Experimental

Check of phenolic absorption between baseline and after 8wks of intake before-after comparison

干预措施: Juice Plus+(R) (Dietary Supplement)

结局指标

主要结局

Absorption kinetics of phenolic acids after 1, 2, 5 and 10 hours, measured via HPLC, evaluated by repeated measures ANOVA, and assessed via SPSS 19.0.

时间窗: 1 year

For the phenolics analyses subjects come to the lab after an overnight fast, and after 2 weeks wash-out of all food supplements and 48 hours wash-out of phytonutrients (phytonutrient-poor diet). To adhere to the phytonutrient-poor diet they receive an exact diet plan in the forefront. This plan will be perused with the research associate. After the baseline blood drawing, they receive 3 capsules of Juice Plus+® consumed with 250ml plain water from the pipe. They will be instructed to swallow one capsule of each blend (fruit, berry, vegetable). During this day 4 additional blood samples will be drawn: 1hr, 2hrs, 5hrs, 10hrs after capsule intake in the morning. After the 2hrs blood sampling the subjects get a standardized, phytonutrient-poor snack: white bread, cheese, ham, milk and water ad libitum. Subjects will receive a list with suggestions of allowed food they could consume on this day.

次要结局

  • Absorption of ß-carotene after 8 weeks of supplementation, measured via HPLC, evaluated by paired t-test, and assessed via SPSS 19.0(1 year)

研究者

发起方
Green Beat
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lamprecht Manfred PhD, PhD

Principal Investigator

Green Beat

研究点 (4)

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