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临床试验/NCT06236620
NCT06236620已完成不适用

Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat

KU Leuven2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年2月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
34
试验地点
2
主要终点
Zinc absorption

研究概览

简要总结

The aim of this project is to investigate whether the increased zinc bio-accessibility values in sprouted or hydrothermally processed wheat is reflected in an increased zinc absorption in human subjects after consuming breakfast flakes derived from such processed wheats.

详细描述

The zinc study is a randomised crossover design with two different meals (control wheat flakes and flakes derived from sprouted wheat or flakes derived from hydrothermally processed wheat) spiked with a specific zinc isotope. The study contains two test groups (I and II) of 26 and 10 participants, respectively. Both test groups will consume the control wheat flakes, whereas test group I will consume the flakes from sprouted wheat and group II the flakes from hydrothermally processed wheat randomised over two test days. An intravenous dose of Zn will be given on day 1 of the study and the zinc isotope composition in the urine of the participants will be measured on day 1,5,6,7 and 8 of the study.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI range 18.5-25.0 kg/m²
  • Regular diet with 3 meals a day (at least 5 times a week)

排除标准

  • Intake of vitamin and/or mineral supplements during and 2 weeks before the stud
  • Intake of antibiotics 3 months prior to the study
  • Intake of medicines that have an impact on the gastrointestinal tract during and 2 weeks before the study
  • Previous or current gastrointestinal (e.g. Crohn's disease), endocrine or eating disorders or other gastrointestinal history
  • Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
  • Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
  • Pregnant or lactating or wishing to become pregnant in the period of the study
  • Allergy or intolerance to wheat (coeliac disease, gluten sensitivity) or citric acid
  • Adherence to vegan or vegetarian diets or special diets (weight loss, gluten-free etc...)
  • Blood donation in the 6 months prior to the study

结局指标

主要结局

Zinc absorption

时间窗: day 1 (before test meal) and day 5,6,7 and 8

Zinc isotope abundance in urine samples

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Verbeke

Professor

KU Leuven

研究点 (2)

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