Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
Recruiting · NCT06286761 · 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 (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use 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 we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time.
Who can take part
Inclusion criteria
- ≥18 and ≤75 years of age
- body mass index ≥18.5 and ≤45 kg/m2
- Weight stable (i.e., ≤3% change)
- ≤150 min of structured exercise/week for at least 2 months before entering the study
- Blood glucose: \< 126 mg/dl fasted, \< 200 mg/dl with 2 hour oral glucose tolerance testing
- Hemoglobin A1C (HbA1C) ≤6.5%
- Dyslipidemia triglycerides ≥125 mg/dL
- No chronic kidney disease
- Not vegan or vegetarian or on high protein diet (e.g. Atkins) or supplements that are not allowed
- No intolerance or allergies to study diet ingredients
- No excessive alcohol or tobacco consumption
Exclusion criteria
- \<18 and \>75 years of age
- body mass index \<18.5 or \>45 kg/m2
- history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for \<5 years, dementia, chronic kidney disease)
- allergies or intolerances to meal ingredients, vegans or vegetarians
- use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc)
- take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements)
- engaged in regular structured exercise \>150 min per week
- alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances
- pregnant women
- persons who use tobacco
- prisoners
- the inability to grant voluntary informed consent.
Where it is running
1 location listed across 1 US state.
- University of Missouri School of Medicine - Columbia, Missouri, United States