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
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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 volunteers
排除标准
- •Metabolic disorder
研究组 & 干预措施
Skimmilk enriched with VD encapsulated in CM
干预措施: Group 1 (Dietary Supplement)
VD will be dissolved in milkfat and homogenized into skimmilk
VD will be dissolved in milkfat and homogenized into skimmilk
干预措施: Group 2 (Dietary Supplement)
3% fat milk wherein the VD will be in CM
3% fat milk wherein the VD will be in CM
干预措施: group 3 (Dietary Supplement)
Placebo: un-enriched skimmilk.
Placebo: un-enriched skimmilk.
干预措施: Group 4 (Dietary Supplement)
结局指标
主要结局
Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.
时间窗: 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
次要结局
未报告次要终点