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NCT Number: NCT06286761

Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri School of Medicine

Columbia, Missouri, 65212, United States

Location status: Recruiting

Location contact

Vasavi Shabrish

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MRI, DEXA, MRS, blood testing, mixed meal, oral glucose tolerance testing

Primary outcomes

  1. Validation and reproducibility testing for blood assays

    Time frame: 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)

  2. Validation and reproducibility testing for endothelial cell collection

    Time frame: through study completion, an average of 10 weeks

    endothelial cell quantity collected

  3. Validation and reproducibility testing for mixed meal ingestion

    Time frame: through study completion, an average of 10 weeks

    tolerability and palatability of meal type (protein concentration, carbohydrate concentration)

  4. Validation and reproducibility testing for glucose tolerance testing

    Time frame: through study completion, an average of 10 weeks

    glucose levels

  5. Validation and reproducibility testing for DEXA

    Time frame: through study completion, an average of 10 weeks

    body composition analysis

  6. Validation and reproducibility testing for MRI

    Time frame: through study completion, an average of 10 weeks

    body composition analysis

  7. Validation and reproducibility testing for MRS

    Time frame: through study completion, an average of 10 weeks

    body composition analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Heather McHatton, MPH, RN

CONTACT

[email protected]

(573) 882-7619

Vasavi Shabrish, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Bettina Mittendorfer

Other

Registry information

Official study title

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Metabolism Research

Acronym: VAL

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 29, 2024
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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