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临床试验/NCT02197624
NCT02197624已完成不适用

Metabolic Adaptation to Plant-based Diets in Asian Populations

Cornell University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2012年6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
57
试验地点
1
主要终点
Genotype at SNP rs9366637

研究概览

简要总结

The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian women. The investigators hypothesize that the genetic variant could enhance iron status and iron absorption in Asian women.

详细描述

To determine the HFE genotype of female Asian study volunteers, we collected venous blood samples and extracted DNA from these blood samples. HFE genotype was determined as CC, CT, and TT and used to assess possible differences in iron status as a function of genotype. To measure the impact of genotype on non-heme Fe absorption, a sub-group of women with the CC (n=10) or TT (n=11) genotype were invited to return for an Fe absorption study. Each volunteer consumed stable 57Fe (as ferrous sulfate). Two weeks after ingesting this tracer, a blood sample was collected from each woman and the amount of non-heme (57Fe) iron incorporated into red blood cells was measured with magnetic sector thermal ionization mass spectrometry. Possible associations between iron status and iron absorption as a function of genotypes were explored. Data from this study will provide information that aims to improve human health by better understanding the iron requirements of individuals with different genetic background.

研究设计

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

入排标准

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

入选标准

  • non-pregnant and between the ages of 18~35 y
  • East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore

排除标准

  • taking or planing to take any vitamin or mineral supplements during the study period
  • pre-existing medical problems that might impact inflammation or Fe status, including malabsorption, blood disorders, ulcers, joint diseases and asthma
  • taking any prescribed medications known to affect iron homeostasis

结局指标

主要结局

Genotype at SNP rs9366637

时间窗: 2 weeks after the participant's visit to the laboratory

At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining genotype.

Serum transferrin receptor

时间窗: Up to 6 months after the participant's visit to the laboratory

At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum transferrin receptor.

Hemoglobin

时间窗: Up to 2 days after the participant's visit to the laboratory

At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of hemoglobin.

Serum Ferritin

时间窗: Up to 6 months after the participant's visit to the laboratory

At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum ferritin.

Non-heme Iron absorption in women with 2 HFE genotypes

时间窗: one month for screening with genotype then 2 weeks for iron absorption study

Women donated a blood sample for genotyping. Women with particular HFE genotypes were invited to return for an absorption study. Two weeks after women consume the iron tracer, a blood sample was obtained to measure the amount of iron absorbed.

次要结局

  • C-reactive protein(Up to 6 months after the participant's visit to the laboratory)
  • Vitamin B-12(Up to 6 months after the participant's visit to the laboratory)
  • Folate(Up to 6 months after the participant's visit to the laboratory)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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