Recruiting

Observational Study

Sponsor:

Bettina Mittendorfer

Code:

NCT06286761

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

endothelial cell collection

Study Details

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.

Conditions

Obesity

Study ID

NCT06286761

Start date

May 8, 2024

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Single arm

For blood assay validation and/or reproducibility testing, blood samples will be taken after an overnight fast or after oral glucose or a mixed meal and analyzed. Measurements will be made by: using different assays to determine best conditions of measurement, or repeat testing on different days. Endothelial cells will be collected from a 20-gauge intravenous catheter. One to six 0.025" J-wires will be sequentially inserted into the catheter. These measurements will allow us to determine: the reproducibility and variability of assays used, best timing of blood and endothelial cell collection and best blood volumes and endothelial cell collection wire passes to reliably perform routine assays. For imaging validation, algorithm development, and/or reproducibility testing, participants may undergo DEXA, MRI, or MRS testing to develop or improve analysis algorithms, to evaluate variability of the measurements, or testing different equipment that measure the same variable.

Interventions

endothelial cell collection

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 outcome measure

  • Validation and reproducibility testing for blood assays [ Time Frame: through study completion, an average of 10 weeks ]
  • Validation and reproducibility testing for endothelial cell collection [ Time Frame: through study completion, an average of 10 weeks ]
  • Validation and reproducibility testing for mixed meal ingestion [ Time Frame: through study completion, an average of 10 weeks ]
  • Validation and reproducibility testing for glucose tolerance testing [ Time Frame: through study completion, an average of 10 weeks ]
  • Validation and reproducibility testing for DEXA [ Time Frame: through study completion, an average of 10 weeks ]
  • Validation and reproducibility testing for MRI [ Time Frame: through study completion, an average of 10 weeks ]
  • Validation and reproducibility testing for MRS [ Time Frame: through study completion, an average of 10 weeks ]

Central Contacts and Locations

Central contacts

Heather McHatton, MPH, RN

(573) 882-7619heathermchatton@health.missouri.edu

Vasavi Shabrish, PhD

v.shabrish@missouri.edu

Locations

University of Missouri School of Medicine

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Vasavi Shabrish

v.shabrish@missouri.edu

More Information

Sponsor

Bettina Mittendorfer

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bettina Mittendorfer on 2026-08-04.