Clinical trial NCT06286761: Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
Official title: Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Metabolism Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: convenience population of volunteers in mid-Missouri region

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.


Eligibility 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.

Primary outcomes:
measure: Validation and reproducibility testing for blood assays
timeFrame: through study completion, an average of 10 weeks
measure: Validation and reproducibility testing for endothelial cell collection
timeFrame: through study completion, an average of 10 weeks
measure: Validation and reproducibility testing for mixed meal ingestion
timeFrame: through study completion, an average of 10 weeks
measure: Validation and reproducibility testing for glucose tolerance testing
timeFrame: through study completion, an average of 10 weeks
measure: Validation and reproducibility testing for DEXA
timeFrame: through study completion, an average of 10 weeks
measure: Validation and reproducibility testing for MRI
timeFrame: through study completion, an average of 10 weeks
measure: Validation and reproducibility testing for MRS
timeFrame: through study completion, an average of 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bettina Mittendorfer, PhD
role: PRINCIPAL_INVESTIGATOR
References: