Oral Release and Pharmacokinetics of Vitamins From a Gum-based Delivery System

Study Design The study will involve two phases. The first phase will be to compare the release of the component vitamins in two chewing gum products into the saliva. This will employ a parallel design in which half the subjects (7 - 8) chew a product marketed for athletes "Sport" and half (7 - 8) chew one marketed for immune system support "Immunity". The second phase will be to compare the acute effects of chewing the two gums on plasma levels of the component vitamins. A single-blinded, double cross-over design with 15 healthy human subjects will be employed. Subjects be randomly assigned to "Sport", "Immunity", or a placebo gum matched for color and flavor but without vitamins. Each phase will be separated by a one-week washout period.

Study Procedures 1. Screening: There will be a phone screening prior to medical screening at the University Park Clinical Research Center (CRC). This will be used to establish explain the study to the prospective participant, establish eligibility and set up an appointment for the medical screen.

2 Medical Screen: Prior to acceptance into the research study, participants must complete consent forms, a medical history form, and have measurements taken (height, weight, blood pressure). If female, a urine pregnancy test will be self-administered to ensure that the subject is not pregnant. If the subject is still eligible after these tests, a small amount of blood (10 mL) will be collected by a CRC nurse using a single needle stick. The blood will be screened for markers of liver function (alanine aminotransferase, aspartate aminotransferase, or bilirubin), kidney function (blood urea nitrogen), and iron status. If a blood sample cannot be collected, the nurse try a second time, or to withdraw from the study. If a second try is unsuccessful, the participant will be excluded from the study.

3 Research Study Overview: If eligible, the subjects will have four study days (1 visit to the Food Science Building and 3 visits to the CRC). The visit to the Food Science Building will be for collection of saliva samples and will last less than 1 h. The three visits to the CRC will be to collect blood samples and will be scheduled from 7:30 am to 6:00 pm. During this day, the subject will be required to remain at the GCRC from 7:30 am to 12:30 pm. The subject will be able to leave after 6:00 pm, but will need to return at 7:30 pm for an additional blood draw.

4 Prior to Study Visits: Subjects will be required to refrain from the use of any vitamin supplement for one week prior to initiation of the study and for the duration of the study. They may consume their normal diet during the study. On the days of the "Blood Collection" visits, the subjects arrive at the CRC having not eaten breakfast. Breakfast will be provided by the investigators prior to the insertion of the catheter. The subjects should drink plenty of water on the day before and the day of the study visit.