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

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS, Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): February 27, 2017

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HS56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No