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

NCT03063502 | Completed

• 1 other identifier: HS56
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  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)

  on day one

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women will be recruited from the area surrounding the BHNRC. There are several thousand government and privately employed workers located within a 10-mile radius of the BHNRC and several residential communities from which a cohort of volunteers will be recruited. The population includes an ethnically diverse group of subjects.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisory Research Physiologist

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: February 27, 2017
• Primary Completion: February 27, 2017
• Study Completion: February 27, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)