Testing Novel Biomarkers of Zinc Status for Use in Human Zinc Supplementation Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in the percent of leukocytic DNA strand breaks
研究概览
简要总结
The purpose of this study is to determine the effect of a moderate decrease in dietary zinc on DNA strand breaks and other cellular zinc biomarkers.
详细描述
Assessing the zinc status of humans has proven to be difficult because of the unique physiological features of zinc homeostasis. Animal and human studies show that a small, vulnerable pool of cellular zinc is sensitive to changes in dietary zinc. The protein, Metallothionein (MT), is made within cells to stabilize this transient zinc pool and to provide a means to 'park' a small zinc reserve. The overall goal is to develop a new method for measuring MT in cells and to assess other cellular responses to changes in small changes in dietary zinc. Culture models of zinc deficiency and excess have been developed and used to test the response of cellular MT levels and mineralization to changes in zinc availability. In Phase II, the changes in the expression of leukocytic zinc transporters and the cellular in vitro uptake of isotopic zinc will be measured. Healthy men will be recruited to participate in a 6-week feeding trial to be followed by a 3-week recovery period. The results of this study will determine if potential new cellular zinc biomarkers respond to changes in zinc status when the men are fed an additional 4 mg zinc/d incorporated into a rice-based meal. These findings will provide essential, new information for designing an efficacy trial of biofortified rice and the zinc status of infants and young children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •willing to limit food and beverage intake to that provided by the study
- •willing to discontinue consumption of alcoholic beverages during the study
- •has an operative understanding of English
- •no plans to move from the area during the study period
排除标准
- •chronic or acute metabolic disease (i.e., diabetes or asthma)
- •taking medications for a metabolic disorder
- •evidence of alcohol abuse or use of illicit drugs
结局指标
主要结局
Change in the percent of leukocytic DNA strand breaks
时间窗: Change in DNA strand breaks measured at baseline, 2, 4, and 3 week intervals with changes in diet zinc
Baseline measurements were made upon entry into the study. Subsequent measurements were made after 2 weeks on a low zinc diet (6 mg/d), 4 weeks on a moderate zinc intake (10 mg/d) and after 3 weeks of consuming a 25 mg zinc supplement.
次要结局
- Cellular zinc biomarkers(At baseline and at 3 time points during the 9 week study: after 2, 6, and 9 weeks.)