NCT06286761 · Bettina Mittendorfer
Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
(VAL)
What this study is about
The purpose of this research study is to validate (check the accuracy of) laboratory assays, given through a vein (IV) 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- the inability to grant voluntary informed consent.
Where
- Columbia, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations