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临床试验/NCT05668832
NCT05668832尚未招募不适用

Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

Martin-Luther-Universität Halle-Wittenberg0 个研究点目标入组 36 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
主要终点
Circulating vitamin D photoisomers

研究概览

简要总结

The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.

详细描述

according to protocol

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Healthy subjects
  • Age between 18 and 65 years
  • Body Mass Index in the range of 18.5 to 29.9 kg/m2

排除标准

  • Acute or chronic illnesses (high blood pressure, heart disease, diabetes, kidney disease, liver disease, alcohol dependence, etc.)
  • Taking medication (except oral contraceptives)
  • Pregnancy or breastfeeding
  • Food intolerances or allergies to mushrooms and dairy products
  • Visits to solariums or previous holidays in southern countries or in the Alps or other high mountains
  • Participation in another study
  • Blood donation during the last 2 months before the start of the study
  • Severe weight loss or weight loss (≥ 3 kg) within the last month

结局指标

主要结局

Circulating vitamin D photoisomers

时间窗: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months

Plasma concentrations of vitamin D photoisomers (such as lumisterol, tachysterol and their hydroxy derivates) after the consumption of the UVB-exposed versus non UVB-exposed button mushrooms

次要结局

  • Plasma lipids(at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months)
  • Inflammation markers(at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months)
  • mRNA and protein expression in peripheral mononuclear blood cells(at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months)
  • Parameters of vitamin D metabolism(at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months)
  • Parameters of mineral metabolism(at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months)

研究者

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

Gabriele Stangl

Prof. Dr.

Martin-Luther-Universität Halle-Wittenberg

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