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临床试验/NCT02697500
NCT02697500已完成不适用

Pre-analytical Sample Handling Conditions and Their Effects on the Human Serum Metabolome

USDA Beltsville Human Nutrition Research Center1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
Selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight.

研究概览

简要总结

This study evaluates how blood serum handling conditions can affect the concentrations of ~1,000 serum metabolites and attempts to quantify the degree of attenuation and/or potential bias in epidemiologic associations that may result from less than optimal sample handling conditions.

详细描述

Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of metabolites simultaneously in a biological matrix, is a versatile analytical technique capable of accelerating biomarker-based discoveries in nutritional science. Recently, metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic studies (2) to identify dozens of novel potential dietary biomarkers. Several large prospective cohort studies, many of which are collaborating in a metabolomics consortium led by the National Cancer Institute, have recently applied metabolomics to banked samples. This has made nutrition-related biomarkers suddenly available for tens of thousands of participants with follow-up for disease endpoints, enabling truly large-scale nutritional biomarkers and disease studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20 to 65 years at beginning of study.
  • BMI between 18.5 and 35.0 kg/m2.

排除标准

  • Presence of cardiovascular disease, kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
  • Unable or unwilling to give informed consent or communicate with study staff.
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

结局指标

主要结局

Selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight.

时间窗: on day one

Serum metabolomics profiling will be conducted at Metabolon, Inc. after the serum has been handled in a number of different ways (refrigerated for different lengths of time and frozen and thawed various numbers of times)

次要结局

未报告次要终点

研究者

发起方
USDA Beltsville Human Nutrition Research Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

David Baer

Supervisory Research Physiologist

USDA Beltsville Human Nutrition Research Center

研究点 (1)

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