Fortification of Milk and Butter With Either vitaminD3 or 25(OH)D3: The Effect on Vitamin D Status and Cardiovascular Disease Risk Markers in Humans
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood
研究概览
简要总结
This study aims to compare the acute effect of consuming milk and butter fortified with either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and cognitive function will be examined.
详细描述
There is mounting evidence to show that vitamin D deficiency may increase the risk of many common and serious diseases, including osteoporosis, cardiovascular disease, some cancers and type 1 diabetes (Holick and Chen, 2008). Hypovitaminosis D is now prevalent in the UK general population. Due to diet and lifestyle changes and the use of sun block products most people do not endogenously synthesise sufficient vitamin D from sunlight exposure (Hyppönen and Power, 2007). Therefore, vitamin D intakes from dietary sources have become very important, however this is limited as there are only a few foods naturally rich in vitamin D.
Some countries (e.g. USA, Canada) fortify milk with vitamin D which results in milk being the major contributor to vitamin D intake. Vitamin D3 is the most common form used for the fortification of currently fortified foods. However, there is now some evidence that 25(OH)D3 can increase vitamin D status of humans more effectively than vitamin D3 (Bischoff-Ferrari et al, 2012; Cashman et al, 2012). To our knowledge, very few human intervention studies have compared the efficacy of 25(OH)D3 versus vitamin D3 to increase vitamin D status, and there has been no acute human study to examine the effect of the both forms of vitamin D fortified dairy products on vitamin D status in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI: 20-35 kg/m2
- •Glucose <7 mmol/l (not diagnosed with diabetes)
- •Total cholesterol <7 mmol/l
- •TAG <4 mmol/l
- •Serum 25(OH)D3 ≤50 nmol/L
- •Normal liver and kidney function
- •Haemoglobin: adult male >125 g/L
排除标准
- •Milk allergy/intolerance or lactose intolerance
- •Cardiovascular, renal, gastrointestinal, respiratory, endocrine disease or cancer
- •Use of nutritional supplements, particularly those containing vitamin D
- •Outdoor workers and use of tanning beds
- •Overseas holidays two months before or during study period
研究组 & 干预措施
breakfast rich in 25(OH) D3
subjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter
干预措施: 25(OH) D3 (Dietary Supplement)
Control
subjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast
干预措施: Control (Dietary Supplement)
breakfast rich in vitamin D3
subjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter
干预措施: vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood
时间窗: Acute study: measured at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour
Change from baseline in the concentrations of vitamin D3 and 25(OH)D3 of the chylomicron
时间窗: Acute study: measured at 0 (baseline), 3, 6, 8 hour
次要结局
- change from baseline in vascular reactivity measured by Endo-PAT(Acute study: measured at 0 (baseline) and the 24 hour)
- change from baseline in vascular reactivity measured by digital volume pulse (DVP)(Acute study: measured at 0 (baseline), 120, 240, 360, 480 min and 24 hour)
- change from baseline in inflammatory markers (tumor necrosis factor alpha, C-reactive protein and interleukin 6) of the blood(Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour)
- change from baseline in cognitive test(Acute study: measured at 0, 480 min and 24 hour)
- change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids)(from 0 to 24 hour, but different measured time points for diferent lipids)
- change from baseline in nitric oxide(Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour)
- change from baseline in markers of insulin resistance (glucose and insulin)(Acute study: measured at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour)
- change from baseline in blood pressure(Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour)
研究者
Julie Lovegrove
Professor Julie Lovegrove
University of Reading
