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

Launched by BETTINA MITTENDORFER · Feb 23, 2024

Keywords

ClinConnect Summary

The VAL study at the University of Missouri is focused on checking the accuracy and consistency of various laboratory tests and research techniques that help us understand metabolic conditions like obesity, pre-diabetes, and type-2 diabetes. The goal is to ensure that new testing methods provide reliable results, which is important for conducting high-quality research on these chronic diseases. Participants in this trial will help researchers compare old and new tests to make sure they work effectively.

To be eligible for the study, participants should be between 18 and 75 years old, have a body mass index (BMI) between 18.5 and 45, and be stable in weight. Participants should also have a specific range of blood glucose and cholesterol levels and must not be overly active, exercising more than 150 minutes a week. Those who are pregnant, have certain health conditions, or follow specific diets like veganism will not be eligible. If chosen for the study, participants can expect to undergo various tests and procedures to help validate these important research methods. This study is a great opportunity to contribute to important research that may improve our understanding of metabolic health.

Gender

ALL

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.