跳至主要内容
临床试验/NCT02535910
NCT02535910Unknown不适用

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

University of Reading1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

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

Experimental

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

Placebo Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Lovegrove

Professor Julie Lovegrove

University of Reading

研究点 (1)

Loading locations...

相似试验