The performance of human clinical and preclinical animal research to test the efficacy of ingredients or products aimed at improving various aspects of human health is greatly needed. This includes the testing of dietary ingredients and finished products marketed as nutraceuticals or dietary supplements. In this modern era of the educated consumer, it is in the company's best interest to perform such investigations (preferably, independent third party) in an attempt to address questions raised in relation to product claims.
Through collaboration with a team of scientists, the CNDSR offers essential product support services for work with nutraceuticals. Our team has all the equipment necessary to provide extensive analytical and bioanalytical characterization of nutraceuticals. Examples include characterization of cGMP-grade nutraceuticals to ensure purity and identity of the product, bioanalytical method development, qualification, and validation using accepted best practices as outlined by the Food and Drug Administration, and characterization of pharmacokinetics in animals and humans. Sponsors will receive a complete analysis of samples including the development of (bio)analytical methods, sample preparation, and data analysis for clinical and non-clinical studies. Support for experimental design along with interpretation of PK/PD modeling data by leading experts in the field is also available.
Bioanalytical, pharmacokinetics, and pharmacodynamics (B/PK/PD) Services
Through collaboration with the colleagues at other institutions, the CNDSR offers essential product support services for work with nutraceuticals. A key component of our B/PK/PD service core is collaboration with state of the art facilities outfitted with all the equipment necessary to provide extensive analytical and bioanalytical characterization of nutraceuticals. Examples include characterization of cGMP-grade nutraceuticals to ensure purity and identity of the product, bioanalytical method development, qualification, and validation using accepted best practices as outlined by the Food and Drug Administration, and characterization of pharmacokinetics in animals and humans. Sponsors will receive a complete analysis of samples including the development of (bio) analytical methods, sample preparation, and data analysis for clinical and non-clinical studies. Support for experimental design along with interpretation of PK/PD modeling data by leading experts in the field is also available.
Cell Culture Experiments
In vivo cell culture testing can be used as a powerful tool to elucidate the safety of a compound or its tissue specific effects. Our labs have the ability to use both immortalized cell lines that can be cultured repeatedly, and primary cells isolated from an animal. Early stage investigations may use cell culture models to determine compound cytotoxicity. We are able to perform several assays in a cell culture model that can determine the effects of a compound on cell proliferation, differentiation, growth and viability. In addition, later stage compounds can be used in this model to elucidate cell specific mechanisms of action that may alter cell metabolism, cell signaling, gene expression, growth and viability. Our team has the experience in helping clients with the selection of appropriate models and assays to meet the specific needs of a particular compound.
Pre-Clinical Animal Studies
Animal models are essential for translating theoretical and cell-based data into living systems, and are critical for testing the efficacy and safety of ingredients, compounds and multiple component systems before advancing to clinical studies. Our research team includes basic scientists, DACLAM boarded veterinary support, and exceptional animal technicians with demonstrated experience in identifying and using the most appropriate animal models to answer specific questions. A key strength is our documented success in developing new animal models for evaluating responses throughout the life history, in health and disease, and in combination with diet and pharmacologic interventions. We have expertise with a diversity of animal species ranging from traditional and non-tradition rodent species, such as mice (wild type and genetically modified), rats, hamsters, voles, mole rats, rabbits and also pigs as a translational species. The animal facilities have advanced diagnostics, including blood and urine chemistries, hematology, blood gases and digital radiography. Our relationship with the Memphis biomedical research community provides additional expertise and facilities. Importantly, our team excels in collaborating with industry partners in the design, performance and interpretation of studies.
Human Studies and Clinical Trials
We are fully equipped to provide a wide variety of human studies of varying design, including single laboratory assessments, placebo-controlled and cross-over designs, randomized and placebo-controlled clinical trials, as well as pharmacokinetic studies. We have expertise in IRB document writing and application approval, protocol development, subject recruitment and retention, data collection and analysis, peer-reviewed manuscript preparation, and professional scientific presentations. The University of Memphis is home to nearly 25,000 students, faculty and staff of varying age, ethnicity and background, making our campus community an excellent source for the recruitment of human subjects.
The list below provides a brief overview of some of the common variables we can include within a research design to test the efficacy of a particular product. This list has specificity to our work involving human subjects. Many of these same variables, or a variation of these variables, can be included within animal study designs.
- Bloodborne, Urine, and Tissue Variables: A variety of biochemical parameters can be assessed to determine overall health. Methods of analytical chemistry and molecular biology can be used to identify/measure more sensitive biomarkers of health and disease. This may include genomic studies.
- Resting metabolic rate and substrate usage: Resting metabolism can be determined using indirect calorimetry, with an analysis of substrate utilization (e.g., lipid and carbohydrate usage).
- Dual Energy X-Ray Absorptiometry (DXA): DXA provides a precise assessment of body composition (fat mass vs. fat free mass), as well as bone mineral content and density.
- Cardiovascular Health: Resting and exercise 12-lead electrocardiograms can be performed, as well as blood pressure assessments.
- Cardiorespiratory/Aerobic Power: Aerobic power can be determined using graded exercise testing performed to exhaustion, coupled with expired breath sample analysis (VO2max).
- Cardiorespiratory/Aerobic Endurance Capacity: Cardiorespiratory endurance capacity is widely used in the study of energy/fatigue in human subjects, both young and old.
- Local Muscular Endurance: Local muscular endurance is assessed using a form of resistance, either body weight, free weight, or machines.
- Local Muscular/Anaerobic Power: Local muscular power is assessed by performing a 30-second maximal sprint using a friction-braked cycle ergometer.
- Local Muscular Strength: Local muscular strength is assessed by performing a one repetition maximum (1RM).
- Rate of Force Development: Using isometric devices integrated with computers, we can determine the rate of force development (Newtons per second) for short (~1ms) to longer (1000 ms) time windows.
- Reaction Time: We use integrated light and force-sensing devices to measure lag time from the onset of the light source to force production at the extremities.
- Central/Peripheral Neural Fatigue: Utilizing electromyography (EMG) integrated with electrical stimulation and force sensors, we can fractionate central and neural contributions to strength and fatigue.
- Lower Extremity 3D Joint Motion: Lower extremity joint motion and mechanical measures are assessed using motion capture during various movement tasks including walking, running and jumping/landing. Specific joint motion details can be assessed for performance improvement in sedentary individuals and older adults, as well as competitive and elite athletes.
- Psychomotor Performance: A variety of psychomotor task performance variables can be assessed to examine the effects of different interventions on memory, learning and motor function (e.g., balance) across different populations.
- Theory-based and technology-enriched health interventions to increase exercise motivation, behavior, adherence, and well-being.