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临床试验/NCT05248737
NCT05248737进行中(未招募)不适用

Empowering and Transforming the US Broiler Production for Growth, Profit and Sustainability

Cornell University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
84
试验地点
1
主要终点
Concentration of plasma DHA concentrations

研究概览

简要总结

The purpose of the research is to evaluate if chicken or eggs obtained from chickens that are fed a diet that contains omega-3 fatty acids (DHA/EPA), or vitamin D (as 25(OH)D) provides additional health benefits by improving the status of omega-3 fatty acids or 25(OH)D in healthy adults who eat this bioenhanced chicken or eggs.

详细描述

The 2015-2020 Dietary Guidelines advocate intake of lean proteins (such as chicken and fish) while limiting intake of saturated fat. Chicken contains similar protein to beef or pork but has less saturated fat. However, chicken, like other terrestrial meats, has little omega-3 polyunsaturated fatty acids such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) and relatively little vitamin D. Vitamin D insufficiency is common in the US and globally, and has been linked to a number of adverse health outcomes. Vitamin D is ingested primarily from fortified dairy products, but recent animal studies have increased the D content of pork and beef, and the DHA content of chicken and of eggs produced from bioenhanced chickens. Moreover, sunlight exposure alone can enhance the 25(OH)D content of chicken. Notably, supplemental 25(OH)D is more effective than vitamin D at improving vitamin D status in humans, but little is known about the bioavailability of 25(OH)D or DHA/EPA enhanced chicken (muscle) or in enhanced eggs produced from supplemented chickens.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adults
  • Non-smoking
  • Age between 18- 35 yo
  • Females: premenopausal and not pregnant or lactating
  • Body mass index (BMI) between 18 - 30 kg/m
  • No preexisting medical complications (such as eating disorders, gastrointestinal disorders, malabsorption diseases, or taking medications known to influence iron homeostasis)

排除标准

  • BMI <18 or > 30 kg/m2,
  • Age <18 y or > 50y,
  • Pregnancy, lactating
  • Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/medication use of medications known to impact DHA/EPA or Vitamin D 25(OH)D absorption
  • Take vitamin and mineral supplementations

结局指标

主要结局

Concentration of plasma DHA concentrations

时间窗: Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal

Measuring plasma DHA concentration across different time points to assess DHA bioavailability and absorption

Concentrations of serum 25(OH)D, vitamin D2, vitamin D3, 1,25(OH)2D and 24,25(OH)2D3 and vitamin D binding protein

时间窗: Baseline, and time course of week 2, week 4, week 6, week 8

Measuring serum 25(OH)D concentration across different time points to assess 25(OH)D bioavailability and absorption

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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