NCT02697500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

Same day

First QC Date

February 12, 2016

Last Update Submit

March 2, 2016

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.

    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)

    on day one

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Biospecimen

Retention: NONE RETAINED

serum and urine

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 12, 2016

First Posted

March 3, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

US(1)