Validation of laboratory measures for metabolism research

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

This study is testing new lab methods to see if they give reliable results for understanding metabolism in people with obesity and related health issues.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Missouri-Columbia (other)
• Locations: 1 site (Columbia, Missouri)
• Trial ID: NCT06286761 on ClinicalTrials.gov

What this trial studies

This research focuses on validating laboratory assays and techniques used in metabolism research, particularly for conditions like obesity and related chronic diseases. It aims to ensure the accuracy and reproducibility of various tests and equipment as new technologies emerge. By comparing results from traditional and modern methods, the study seeks to confirm that consistent and reliable data is obtained for high-quality research. The study will involve the collection of endothelial cells as part of the methodology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a body mass index between 18.5 and 45 kg/m2 who are weight stable and meet specific metabolic health criteria.

Not a fit: Patients outside the age range of 18 to 75, with a BMI below 18.5 or above 45, or those with significant organ dysfunction will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of metabolic research, leading to better understanding and treatment of obesity and related conditions.

How similar studies have performed: Other studies have shown success in validating laboratory measures for metabolic research, indicating that this approach is supported by prior findings.

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.

Where this trial is running

Columbia, Missouri

• University of Missouri School of Medicine — Columbia, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Bettina Mittendorfer, PhD — University of Missouri-Columbia
• Study coordinator: Heather McHatton, MPH, RN

Conditions: Obesity