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临床试验/NCT02543671
NCT02543671已完成不适用

Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency

Harokopio University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
serum 25-hydroxyvitamin D concentration

研究概览

简要总结

The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study.

详细描述

Vitamin D status in postmenopausal women is of interest because of the association of low vitamin D status with increased risk of osteoporosis and related fractures. In addition, since there is increasing evidence that the dietary supply is often insufficient to offset the seasonal deficit in sunlight during winter months, fortified food and supplements are becoming important sources of dietary vitamin D intake to achieve optimal vitamin D status, especially in this high risk population. Although most studies have examined the effectiveness of vitamin D enriched milk and yogurt, there have been limited studies also exploring the effectiveness of vitamin D enriched cheese in enhancing vitamin D status and preventing vitamin D deficiency. However, fortification of cheese with vitamin D has certain technological considerations, particularly for reduced-fat varieties considering that vitamin D is a fat soluble nutrient.

The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study. .

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
55 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • subjects are eligible if they are 55-75 years of age
  • being at menopause for more than 5 years
  • they used to consume cheese daily
  • those with a Body Mass Index (BMI) range 20-33kg/m2

排除标准

  • having any disease/ pathology that interacts with vitamin D metabolism
  • taking medications that interact with vitamin D metabolism or vitamin D supplements for medical reasons (e.g. osteoporosis)
  • planned vacation to a sunny holiday destination during the intervention period
  • having a cow's milk allergy
  • having a drugs and/or alcohol abuse

结局指标

主要结局

serum 25-hydroxyvitamin D concentration

时间窗: 8 weeks

次要结局

  • physical functioning scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)
  • role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)
  • role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)
  • vitality scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)
  • emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)
  • social functioning scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)
  • bodily pain scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)
  • general health scale, Short Form 36 health survey questionnaire (SF-36)(8 weeks)

研究者

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

Yannis Manios

Associate Professor

Harokopio University

研究点 (2)

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