Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms
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
- 是
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
研究组 & 干预措施
oral intake of UVB-exposed mushrooms
Daily intake of 500 g of UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8)
干预措施: UVB-exposed button mushrooms (Dietary Supplement)
oral intake of non-UVB-exposed mushrooms
Daily intake of 500 g of non-UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8)
干预措施: UVB-exposed button mushrooms (Dietary Supplement)
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
Gabriele Stangl
Prof. Dr.
Martin-Luther-Universität Halle-Wittenberg