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临床试验/NCT02155062
NCT02155062已完成不适用

Urinary Alkylresorcinol Metabolites as a Biomarker of Whole Grain Wheat and Rye Intake

King's College London2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
24-h urinary DHBA:DHPPA ratio

研究概览

简要总结

Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting this proposal. Different AR species are present in characteristic quantities in WG wheat in comparison to WG rye cereals, which can allow identification of the main source of WG (wheat or rye) in individuals by analysing the AR concentrations in blood. However the patterns of urinary AR metabolite excretion following wheat or rye intake have not yet been investigated to determine if there are differences according to WG source.

The present study aims to:

(i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine samples after following a predominantly WG rye-based diet in comparison to a predominantly WG wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the validity and reproducibility of AR metabolites in spot urine samples in comparison to 24 hour urine samples.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass intake 18.5-30.0 kg/m2
  • Weight stable for 2 months
  • Generally healthy

排除标准

  • Previous or current chronic disease including heart disease, diabetes, gastrointestinal, liver, renal or endocrine disorders
  • Drug or alcohol misuse in the last year
  • Current pregnancy or lactation
  • Weight change of >3 kg in the last two months
  • Current regular user of certain prescription medications (except contraceptives)
  • Unwilling to consume or to stop consuming WG wheat, WG rye or refined cereals
  • Unwilling to discontinue multivitamins/dietary supplements during study

结局指标

主要结局

24-h urinary DHBA:DHPPA ratio

时间窗: Endpoint (Day 3)

DHBA: 3,5-dihydroxybenzoic acid DHPPA: 3-(3,5-dihydroxyphenyl)-propanoic acid DHBA \& DHPPA are the main AR metabolites excreted in urine

次要结局

  • DHBA:DHPPA ratio in morning spot urine(Endpoint (Day 3))
  • Total 24-h urinary AR metabolite (DHBA + DHPPA) excretion(Endpoint (Day 3))
  • Total 24-h urinary DHBA excretion(Endpoint (Day 3))
  • Total 24-h urinary DHPPA excretion(Endpoint (Day 3))
  • 24-h urinary total AR (DHBA+DHPPA):creatinine ratio(Endpoint (Day 3))
  • 24-h urinary DHBA:creatinine ratio(Endpoint (Day 3))
  • 24-h urinary DHPPA:creatinine ratio(Endpoint (Day 3))
  • DHBA:creatinine ratio in morning spot urine sample(Endpoint (Day 3))
  • DHPPA:creatinine ratio in morning spot urine sample(Endpoint (Day 3))
  • Total AR (DHBA+DHPPA):creatinine ratio in morning spot urine sample(Endpoint (Day 3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Julia Darzi

Lecturer Nutrition and Dietetics

King's College London

研究点 (2)

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