Recruiting nowNot applicableObservational
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionObesity
Full registry criteria
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.
Treatments and study arms
endothelial cell collection
Other
Participants may opt to have testing performed including blood sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS to investigate use of different assays, different sample treatment approaches to determine optimal conditions that produce the most accurate and reproducible results, and/or repeat testing on different days or with different equipment that measures the same variable.
Primary outcomes
Validation and reproducibility testing for blood assaysthrough study completion, an average of 10 weeksinsulin, C-peptide, glucagon, substrates (free fatty acids, glucose, ketone bodies) and biomarkers of substrate metabolism (e.g., cytokines and adipokines)
Validation and reproducibility testing for endothelial cell collectionthrough study completion, an average of 10 weeksendothelial cell quantity collected
Validation and reproducibility testing for mixed meal ingestionthrough study completion, an average of 10 weekstolerability and palatability of meal type (protein concentration, carbohydrate concentration)
Validation and reproducibility testing for glucose tolerance testingthrough study completion, an average of 10 weeksglucose levels
Validation and reproducibility testing for DEXAthrough study completion, an average of 10 weeksbody composition analysis
Validation and reproducibility testing for MRIthrough study completion, an average of 10 weeksbody composition analysis
Validation and reproducibility testing for MRSthrough study completion, an average of 10 weeksbody composition analysis
