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

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT02697500

HS53

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.