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临床试验/NCT01443897
NCT01443897已完成不适用

Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults

USDA, Western Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Change in serum Vitamin D2

研究概览

简要总结

This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase their vitamin D2 content are actually a good source of vitamin D when consumed daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which will be a standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in vitamin D status affects the immune system by decreasing it's level of activation, which may be abnormally elevated in vitamin D deficiency.

详细描述

Volunteers will be asked to consume a standard meal (lunch) containing one serving of mushrooms daily for six weeks (7 days per week). With the meal, they will also need to take one capsule. The capsule will be either a placebo or will contain vitamin D. The purpose of the vitamin D in the capsule is to determine if the vitamin D from the mushrooms is absorbed as well as vitamin D from a capsule. The total dose of vitamin D that volunteers will receive each day from mushrooms and capsule together will always be the same and will be one of three doses: (1) little or no vitamin D (placebo); (2) 400 IU, which is near the current recommended intake and (3) 1,000 IU, which is up to five-fold higher than the current recommended intake, depending on your age. Both levels of vitamin D are safe. In addition to consuming the meals and taking the capsules, up to 20 mL (4 teaspoons) of blood will be drawn at three times during the study just before the mushroom-containing lunch is provided: (1) at the beginning of the study before the first meal; (3) after three weeks; (3) at the end of the study. The purpose of the blood draw is to measure vitamin D in your blood and to measure the level of activation of your immune system by measuring markers of immune activation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • willing to consume a lunch meal 7 days per week for 6 weeks containing mushrooms
  • willing to stop eating other sources of mushrooms
  • willing to discontinue taking vitamin D and other dietary supplements
  • estimated low vitamin D status based on dietary questionnaire, skin reflectance, and sun behavior

排除标准

  • women who are pregnant or breastfeeding
  • volunteers with anemia
  • volunteers with evidence of underlying disease affecting vitamin D metabolism
  • volunteers taking medications altering vitamin D metabolism

结局指标

主要结局

Change in serum Vitamin D2

时间窗: 0, 3 and 6 weeks

Serum vitamin D 2 will be measured in serum.

次要结局

  • Change in serum markers of inflammation(0, 3, and 6 weeks)

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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