Obesity
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Bettina Mittendorfer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation and reproducibility testing for blood assays | through study completion, an average of 10 weeks | insulin, 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 collection | through study completion, an average of 10 weeks | endothelial cell quantity collected |
| Validation and reproducibility testing for mixed meal ingestion | through study completion, an average of 10 weeks | tolerability and palatability of meal type (protein concentration, carbohydrate concentration) |
| Validation and reproducibility testing for glucose tolerance testing | through study completion, an average of 10 weeks | glucose levels |
| Validation and reproducibility testing for DEXA | through study completion, an average of 10 weeks | body composition analysis |
| Validation and reproducibility testing for MRI | through study completion, an average of 10 weeks | body composition analysis |
| Validation and reproducibility testing for MRS | through study completion, an average of 10 weeks | body composition analysis |
Countries
United States
Contacts
Primary ContactHeather McHatton, MPH, RN
Backup ContactVasavi Shabrish, PhD
Outcome results
None listed