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

Completed

• Conditions: Healthy

• Registration Number: NCT03063502
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

Brief Summary

This study evaluates how urine handling conditions can affect the concentrations of \~1,000 urine 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2017-02-27
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight.	on day one	Urine metabolomics profiling will be conducted at Metabolon, Inc. after the urine has been handled in a number of different ways (placed into tubes with various additives, refrigerated for different lengths of time, and frozen and thawed various numbers of times)

Trial Locations

Locations (1)

USDA-ARS, Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States