Clinical Trials
Design:
Create protocol outlining the study design and procedures to answer a research question.
Conduct:
Adhere to ethical standards and regulations throughout the entire lifecycle of a research study from start-up to close-out. Includes all activities required to ensure participant safety, maintain data integrity, and achieve reliable, unbiased results.
Report/Manuscript:
Provide a clinical study report or manuscript that details the methods, results, and conclusions of a clinical trial.
Management:
Oversee independent research site(s) that recruit, enroll, and collect data from participants to confirm adherence to the study protocol.
While we assess a wide range of products,
our niche includes:
Medical & Functional Foods
Consumer Health Products
Medical Devices
Dietary Supplements
Pharmaceuticals
Novel Food Ingredients
Our partner research sites, both private and academic, are located in:
Florida
Illinois
Indiana
Kentucky
Texas
Virginia
Our trials include access to the following populations:
Minority (African American, Hispanic, Asian American)
Elderly
Healthy across the age spectrum
Specific diseases/conditions
Dyslipidemias
Diabetes, prediabetes
Obesity, metabolic syndrome
Cardiovascular disease
Others
Assessment Capabilities
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Body composition (dual x-ray absorptiometry), lipoprotein lipid and particle concentrations, apolipoproteins, insulin sensitivity and secretion, markers of inflammation and oxidative stress, plasma and tissue fatty acids, resting and ambulatory blood pressures
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Appetite regulation, body weight/composition, exercise capacity, resting and exercise energy expenditure and substrate oxidation, nutrient bioavailability, controlled feeding, gastrointestinal tolerability
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Computerized test batteries for assessment of comprehension, attention, executive function, memory, problem solving, processing speed, reaction time