Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in the Milk-fat, or in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment
The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in absence of fat.
As a model the investigators have chosen nonfat yoghurt. The investigators will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by CMIA. In vitro simulated digestion will be studied.
Expected results: The BA of VD in CM would not be lower than in fat
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Metabolic disorder
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Skimmilk enriched with VD encapsulated in CM
|
Skimmilk enriched with VD encapsulated in CM
|
|
有源比较器：VD will be dissolved in milkfat and homogenized into skimmilk
|
VD will be dissolved in milkfat and homogenized into skimmilk
|
|
有源比较器：3% fat milk wherein the VD will be in CM
|
3% fat milk wherein the VD will be in CM
|
|
有源比较器：Placebo: un-enriched skimmilk.
|
Placebo: un-enriched skimmilk.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.
大体时间：1 year
|
As a model we have chosen nonfat yoghurt.
We will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk.
120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt.
Blood will be drawn before ingestion and on days 1,7,14.
25(OH)D will be det.
by
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 3000007066
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Group 1的临床试验
-
Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
-
Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的
-
Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的
-
Northern Illinois UniversityUniversity Autonoma de Santo Domingo终止