Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
Recruiting · NCT07083557 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bettina Mittendorfer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.
Who can take part
Inclusion criteria
- ≥18 and ≤100 years of age
- body mass index ≥16.0 and ≤60 kg/m2
Exclusion criteria
- \<18 and \>100 years of age
- body mass index \<16.0 or \>60 kg/m2
- allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians
- use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay/techniques being evaluated
- engaged in regular structured exercise \>150 min per week unless needed for validation of the assay/technique being evaluated
- significant organ system dysfunction or diseases, except those that are sought for validation of the assay/technique being evaluated
- alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay/technique being evaluated
- pregnant women, persons who smoke, prisoners, and inability to grant voluntary informed consent.
Where it is running
2 locations listed across 1 US state.
- University of Missouri-Columbia - Columbia, Missouri, United States
- University of Missouri-Columbia - Columbia, Missouri, United States