Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in 25-hydroxyvitamin D (25(OH)D)
研究概览
简要总结
The proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed in 5 different forms:
i) a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched fat-free dairy drink
详细描述
This postprandial study will recruit healthy males and females aged 18 and over. Upon completion of informed consent procedures and successful screening, the volunteers will complete 4 study visits. Participants will consume a standardised meal the evening before each test day, and will arrive in the morning to the research facility in UCD after an overnight fast of 12 hours.
On the study test days, volunteers will be given one of the following vitamin D treatments in a dairy drink, followed by a low-fat breakfast.
- mixed micelles
- olive oil
- fish oil
- fat-free
Participants will also be given a low-fat lunch 5 hours after the supplement is consumed. Volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood sample will be taken. Following ingestion of the vitamin D supplements blood samples will be taken at 0,2,4,6, and 8 hours post ingestion. A 10mL sample will be collected at each time point. In total, 60mL of blood will be collected over 24 hours. The participant's food intake will be recorded during the visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
single-blinded crossover study
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 men and women
排除标准
- •Pregnant or lactating Smokers Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.
- •An inability to read, write or understand English Following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, Crohn's disease Disease or condition that requires chronic therapeutic nutritional or medical treatment.
- •Those taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months
研究组 & 干预措施
Vitamin D enriched mixed micelles dairy drink
20ug vitamin D in pre-formed mixed micelle dairy drink
干预措施: Vitamin D supplement (Dietary Supplement)
Vitamin D enriched olive oil dairy drink
20ug vitamin D in olive oil dairy drink
干预措施: Vitamin D supplement (Dietary Supplement)
Vitamin D enriched fish oil dairy drink
20ug vitamin D in fish oil dairy drink
干预措施: Vitamin D supplement (Dietary Supplement)
Vitamin D enriched fat-free dairy drink
20ug vitamin D in fat-free dairy drink
干预措施: Vitamin D supplement (Dietary Supplement)
结局指标
主要结局
Change in 25-hydroxyvitamin D (25(OH)D)
时间窗: 8 hours
Change in 25(OH)D up to 8 hours after consuming the vitamin D enriched dairy drink
次要结局
未报告次要终点
研究者
Aifric O'Sullivan
Assistant Professor
University College Dublin