Clinical Trials

FOODplus, through its joint venture partner at the Women and Childrens Health Research Institute (WCHRI) and other long-term collaborators at Flinders Medical Centre and the Royal Adelaide Hospital, undertakes clinical and nutritional trial using various targeted sub-populations of people. Many of these trials are double-blind randomized controlled nutritional interventions, with large study populations (eg up to 2,500 participants), both short- and long-term, often multi-centred, and involve complex pre-selection processes and monitoring. Together with our collaborators (DMAC) we have developed a unique electronic project/data management system that allows us to monitor in real time factors such as enrolment, adherence to the protocol and data collection quality regardless of the location of the study sites. We specialize in high quality maintenance of study cohorts to facilitate follow-up studies several years later.

Some examples of past and current trials:

• DINO (Docosahexaenoic acid (DHA) for the improvement of neurodevelopmental outcome in preterm infants) n = 657
• DINO 7 - follow up at age 7. Evaluation of cognitive function.
• DOMInO (DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children) n=2,400
• PINK (Pregnancy Iodine and Neurodevelopment in Kids) n=1,500
• TIGGA (Growth and nutritional status of infants fed formula based on goat milk or cow milk) n=301 randomly selected families
• DHAllergy (Fish oil in pregnancy to reduce allergy symptoms in early childhood) n=706 families
• ChOIR (Fish oil in pregnancy and effect on body mass in early childhood) n=638 families
• STEP (Development of egg allergy in infants related to timing of introduction of egg protein into solid diet) n=1,512
• Fish oils and their effect on incidence of post-operative atrial fibrillation after cardiopulmonary bypass surgery. n=200
• FOSTAR (Fish oil in osteoarthritis).

Clinical trials are logistically challenging, expensive and clearly require justification to, and approval by, human research ethics committees. Human trials are usually only undertaken when the intervention is supported by data from in vitro and/or animal models. FOODplus has a number of in vitro and animal models of nutritionally relevant disease conditions (eg diabetes, food allergy, metabolic syndrome, obesity). These studies are logically less challenging and less expensive than clinical trials, but all such trials still need to be approved by an animal research ethics committee.