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

Sponsor
USDA Beltsville Human Nutrition Research Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02697500
Collaborator
(none)
13
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    13 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Mar 1, 2016
    Actual Primary Completion Date :
    Mar 1, 2016
    Actual Study Completion Date :
    Mar 1, 2016

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USDA-ARS, Beltsville Human Nutrition Research Center Beltsville Maryland United States 20705

    Sponsors and Collaborators

    • USDA Beltsville Human Nutrition Research Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Baer, Supervisory Research Physiologist, USDA Beltsville Human Nutrition Research Center
    ClinicalTrials.gov Identifier:
    NCT02697500
    Other Study ID Numbers:
    • HS53
    First Posted:
    Mar 3, 2016
    Last Update Posted:
    Mar 4, 2016
    Last Verified:
    Mar 1, 2016

    Study Results

    No Results Posted as of Mar 4, 2016