Location: Southeast Area
2012 Annual Report
Due to the crossover design of the trial, participants are randomized to either the intervention or control arm initially (first phase), and after a one month wash-out period, begin the other arm (second phase) of the trial. Participant recruitment and enrollment is an ongoing process due to the nature of the study; hence participants have staggered start dates. Internal Review Board approval (necessary for the conduction of human research) was received for the project in December 2010. Recruitment for and the first arm of the trial began in August 2011, and the second phase of the trial began in January 2012. As of June 14, 2012, 41 subjects have been screened for the trial, and of these, 12 have been enrolled. Of these 12, seven subjects have completed the first phase; and of these seven, four subjects are currently in the second phase, and two subjects have completed both phases. Five subjects dropped from the trial in the first phase due to various reasons including pregnancy, dislike of the food, logistical issue, start of new job, and surgery. One subject completed the first phase of the trial and dropped in the second phase due to the development of cancer.
The following food products have been produced for the project: hamburgers, sloppy Joes, chicken nuggets, buns, bagels and cream cheese, oatmeal bars, caramel bars, brownies, and muffins, enchilada pie, spaghetti, lasagna pie, macaroni and cheese, and frozen yogurt. Due to this project being earmarked for early termination, the effective termination date for this agreement was changed from August 31, 2013 to September 30, 2012. While subject recruitment and enrollment will not be completed by the end of FY 2012, it is anticipated that the trial will continue using funds from another source. Analysis of the biological study samples collected from the participants will also occur after the project is terminated using funds from another source.