Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Vitamin D status
研究概览
简要总结
This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups:
- Vitamin D enriched (20ug) olive oil emulsion drink
- Vitamin D enriched (20ug) coconut oil emulsion drink
- Placebo emulsion drink
- Vitamin D supplement (20ug) Participants will be randomized to 1 of 4 intervention group.
Hypothesis 1: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention.
Hypothesis 2: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.
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
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
排除标准
- •Pregnant/lactating
- •Individuals who are not free-living
- •An inability to read, write or understand English
- •Following a strict diet for any reason, insulin dependent diabetes, coeliac etc.
- •Disease that requires chronic therapeutic nutritional or medical treatment
- •Those with conditions that may affect kidney function
- •Those with osteoporosis
- •Those taking supplemental vitamin D
- •Those who have been on a sun holiday in the last 2 months
- •Those with a milk protein allergy or lactose intolerance
研究组 & 干预措施
Vitamin D enriched (20 mcg/day) olive oil emulsion drink
30 mL vitamin D enriched drink consumed daily for 4 weeks
干预措施: Vitamin D enriched (20 mcg/day) olive oil emulsion drink (Dietary Supplement)
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
30 mL vitamin D enriched drink consumed daily for 4 weeks
干预措施: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink (Dietary Supplement)
Placebo coconut oil emulsion drink
30 mL placebo drink consumed daily for 4 weeks
干预措施: Placebo coconut oil emulsion drink (Dietary Supplement)
Vitamin D supplement (20 mcg/day)
Vitamin D supplement consumed daily for 4 weeks
干预措施: Vitamin D supplement (20 mcg/day) (Dietary Supplement)
结局指标
主要结局
Vitamin D status
时间窗: Baseline to 28 days
Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)
次要结局
未报告次要终点
研究者
Aifric O'Sullivan
Assistant Professor
University College Dublin