Health Evaluation of Mushrooms withVitamin D2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in 25OHD at week 4
研究概览
简要总结
Although Taiwan has plenty of sunshine, the intake of vitamin D and the concentration of 25(OH)D in the blood are low. Ingestion of mushrooms and extracts rich in D2 can increase the nutritional source of vitamin D. The purpose of this study is to evaluate the intake of D2 mushrooms and extracts in humans to achieve the effective concentration of 25(OH)D in the serum and recommendations for health improvement.
详细描述
The subjects were divided into 3 groups: no mushroom intervention, intervention with D2 10ug Pleurotus citrinopileatus after bio-optics optimization (low dose group) or intervention with D2 100ug Pleurotus citrinopileatus after bio-optics optimization (high dose group). The low-dose group took D2 10ug per day, and the high-dose group received D2 100ug per day for a total of 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy human
排除标准
- •Any acute disease, such as infection, stroke, myocardial infarction or major surgery within three months, upper or lower gastrointestinal bleeding, blood pressure, and poor blood sugar control will be excluded.
- •Chronic diseases, such as malignant tumors, infection with human immunodeficiency virus (HIV) and related diseases, liver cirrhosis, or those with liver function exceeding 3 times the normal value (more than 120 IU/L), renal function (Cr) more than 2.5 mg /dl, chronic anemia (Hb <9 g/dl), metabolic diseases except diabetes (such as thyroid/parathyroid dysfunction), and those who have undergone abdominal surgery to cause intestinal sticking are excluded.
- •Women who are pregnant or breastfeeding will be excluded.
- •Those who use steroids, supplements with vitamin D-containing dietary supplements and hormones will be excluded.
- •Those with blood 25(OH)D concentration > 30 ng/ml will be excluded.
- •Those who are unwilling to fill out the consent form and refuse the questionnaire survey.
结局指标
主要结局
Change from baseline in 25OHD at week 4
时间窗: Baseline and week 4
The participants' blood was taken to analyze the concentration of 25OHD to compare the changes between baseline and 4 weeks later. 25OHD concentration standard is: 25OHD \< 20 ng/ml: deficiency 20 ng/ml \< 25OHD \< 30 ng/ml: Insufficiency 25OHD \> 30 ng/ml: Normal
次要结局
未报告次要终点