Special edition: Bone & Joint Health
Study design
A major challenge to date is that many studies have focused on subjects with osteoporosis, but claims cannot be made on disease states. Designing studies to measure changes in healthy subjects pose challenges but are not impossible.
“One approach to the design of a research study investigating effects of a dietary supplement on joint health would be to recruit apparently healthy individuals with self-reported joint pain and put them through a stress test of some type. For example, a timed step-mill protocol with assessment of joint pain using a visual analog scale,” explained Chad Cook, PhD, Senior Scientist, Biofortis Clinical Research, a Mérieux NutriSciences company.
“Participants that reach or pass a certain threshold for joint pain in response to the stress test would likely be good candidates for a clinical study of a dietary supplement intended to evaluate a non-nutritional effect on the structure or function of the body in generally healthy individuals who experience knee joint discomfort with physical activity.”