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临床试验/NCT03248115
NCT03248115已完成不适用

Bioavailability of Green Tea and Coffee Polyphenols in Healthy Participants

MRC Human Nutrition Research2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Change from baseline phenolic metabolites in urine at 2 weeks

研究概览

简要总结

There is little information on the dietary intake, absorption, metabolism and bioavailability (degree to which a substance becomes available to the target tissues upon administration) of polyphenols (natural substances present in a variety of foods) in human participants.

This study assessed the bioavailability in healthy participants of polyphenols from 2 supplements containing green tea and green coffee extracts.

Eleven participants were recruited and their habitual diet was assessed to estimate polyphenol intake. After completing a 24-hour urine collection, participants were given six green tea extract and three green coffee extract tablets, which they took daily for a period of 8 weeks. No tablets were taken during the last 4 weeks of the study. Further 24-hour urines were collected at 2, 4, 8 and 12 weeks.

Participants were required to attend HNR (medical laboratory) the day after each 24hour urine collection. At these visits, they were asked to bring along their urine collections, completed documents (urine collection sheet, checklist for tablet intake/side effects) and any remaining supplements, which were used to assess tablet compliance.

The investigators identified and quantified the amount of polyphenols in the supplement tablets as well as the amount of polyphenols and their metabolites in urine. The investigators then evaluated polyphenol bioavailability from the relationship between their dietary intake and urinary output.

Evidence from this research could inform future intervention studies by providing data on the bioavailability of green tea and coffee polyphenols, and on the individual differences related to phenolic intake.

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
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women.
  • 18-45 years of age.
  • BMI between 18.5 and 24.9 kg/m2.

排除标准

  • Allergy or intolerance to intervention supplements.
  • Chronic, acute or active inflammatory conditions, haematological disorders, or any other systemic illness of renal, hepatic or gastrointestinal origin.
  • Major surgical operations in the gastrointestinal tract or medical treatment for gastrointestinal problems.
  • Active cancer or diagnosis of malignancy within the last five years.
  • Pregnant, lactating, contemplating pregnancy.

结局指标

主要结局

Change from baseline phenolic metabolites in urine at 2 weeks

时间窗: Week 0 -before supplementation- and week 2

Assessment of the profile of metabolites coming from green tea and green coffee phytochemicals in urine

Change from baseline phenolic metabolites in urine at 4 weeks

时间窗: Week 0 -before supplementation- and week 4

Assessment of the profile of metabolites coming from green tea and green coffee

Change from baseline phenolic metabolites in urine at 8 weeks

时间窗: Week 0 -before supplementation- and week 8

Assessment of the profile of metabolites coming from green tea and green coffee

Change from baseline phenolic metabolites in urine at 12 weeks

时间窗: Week 0 -before supplementation- and week 12 -4 weeks after finishing the supplementation period-

Assessment of the profile of metabolites coming from green tea and green coffee

次要结局

  • Phenolic compounds in tablets(Through study completion, an average of 3 months)

研究者

发起方
MRC Human Nutrition Research
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Virginia Tomatis

Principal Investigator

MRC Human Nutrition Research

研究点 (2)

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