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临床试验/NCT03451214
NCT03451214已完成不适用

Effect of Zinc-Biofortified Wheat on Essential Fatty Acid Metabolism in Men

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Lipidomics changes

研究概览

简要总结

The purpose of this study is to determine the effect of different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers

详细描述

This research is a dietary intervention study designed to evaluate the effect of progressive changes in Zn intake on fatty acid metabolism and to correlate those changes with biomarkers of dyslipidemia and insulin resistance. The main objective is to validate plasma fatty acid metabolism as a biomarker of inadequate Zn intake in subjects consuming identical diets with specific Zn content. The relative sensitivity of some fatty acid enzyme activities will also be compared to the DNA strand breaks. In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia. Similar correlational analyses will be performed with clinical measures of inflammation and insulin resistance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

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
  • willing to stop zinc supplementation 4 weeks prior to start of 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
  • smoker or user of nicotine products
  • history of alcohol abuse, or use of illicit drugs.
  • Is underweight or overweight, body mass index (BMI) < 18 or > 30 kg/m2.

研究组 & 干预措施

diet zinc

Experimental

3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d

干预措施: Diet Zinc (Other)

结局指标

主要结局

Lipidomics changes

时间窗: Day 0, day 15, day 57 and day 71

Change in Fatty acid metabolism

DNA strand breaks changes

时间窗: Day 0, day 15, day 57 and day 71

change in COMET assay olive-tail moments

次要结局

  • Polar Metabolomics changes(Day 0, day 15, day 57 and day 71)
  • Fat allocation changes(Day 0, day 15, day 57 and day 71)
  • Mineral analysis changes(Day 0, day 15, day 57 and day 71)
  • Body weight changes(Day 0, day 15, day 57 and day 71)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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