Human Intervention Study to Increase 25-hydroxyvitamin D Levels by Regular Consumption of Wheat Germ Oil (UV-treated) vs. Wheat Germ Oil Untreated (Control)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Vitamin D status
研究概览
简要总结
The interventional study will evaluate effectiveness and potential of a regularly consumption of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D levels ín humans.
详细描述
The interventional study in parallel design will evaluate the effectiveness and potential of a daily consumption of wheat germ oil (UV treated vs. untreated) to increase plasma vitamin D levels in humans.
Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study.
Half of the participants will consume UV-treated wheat germ oil (intervention) and the other part will consume traditional wheat germ oil (untreated, control). The subjects will consume 10 ml of wheat germ oil per day over an entire period of 6 weeks (no follow-up).
On the basis of the planned human intervention study (randomized, single-blind, parallel design) it will be investigated to what extent a regular consumption of wheat germ oil (UV-treated) can contribute to the increase of plasma 25 (OH) D levels.
The comparison is made against the intake of traditional (untreated) wheat germ oil (control).
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
- Single (Participant)
盲法说明
The wheat germ oil is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018).
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects
- •plasma 25(OH) vitamin D < 50 nmol/l
- •nutritional habits: western diet
排除标准
- •intake of lipid-lowering medications
- •gastrointestinal diseases, diabetes mellitus type I and II
- •intake of supplements (vitamin D supplements, fish oil capsules, vitamins and minerals) 3 months before and during the study
- •relevant food allergies / intolerances
- •visit to the solarium (within 4 weeks before beginning of the study and during the study)
- •stay in the mountains / skiing (within 4 weeks before beginning of studies and during the study)
结局指标
主要结局
Vitamin D status
时间窗: change from baseline after 3 and 6 weeks
plasma levels of 25OHD2, 25OHD3 (nmol/l)
次要结局
- Blood lipids(change from baseline after 3 and 6 weeks)
- soluble Klotho (sKlotho)(change from baseline after 3 and 6 weeks)
- Vitamin D forms 1(change from baseline after 3 and 6 weeks)
- Insulin(change from baseline after 3 and 6 weeks)
- Fatty acid distribution (erythrocytes)(change from baseline after 3 and 6 weeks)
- Blood glucose(change from baseline after 3 and 6 weeks)
- Fibroblast growth factor 23 (FGF23)(change from baseline after 3 and 6 weeks)
- Vitamin D forms 3(change from baseline after 3 and 6 weeks)
- Vitamin D forms 4(change from baseline after 3 and 6 weeks)
- Vitamin D forms 2(change from baseline after 3 and 6 weeks)
研究者
Christine Dawczynski,PhD
Head of the Junior Research Group Nutritional Concepts
University of Jena