Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

PRIMARY OBJECTIVES:

I. To select an optimal black raspberry confection based on altered gene expression and
chemical profiles in healthy individuals exposed to 3 black raspberry-based amorphous
functional confections with modulated bioactive release rate at two doses (4 g and 8 g).

OUTLINE: Participants are randomized to 1 of 6 arms after 2 weeks.

ARM I: Participants receive black raspberry (BRB) confection 1 fast release orally (PO) 4-6
hours apart thrice daily (TID) for 2 weeks.

ARM II: Participants receive BRB confection 2 fast release PO 4-6 hours apart TID for 2
weeks.

ARM III: Participants receive BRB confection 1 intermediate release PO 4-6 hours apart TID
for 2 weeks.

ARM IV: Participants receive BRB confection 2 intermediate release PO 4-6 hours apart TID for
2 weeks.

ARM V: Participants receive BRB confection 1 prolonged release PO 4-6 hours apart TID for 2
weeks.

ARM VI: Participants receive BRB confection 2 prolonged release PO 4-6 hours apart TID for 2
weeks.

Inclusion Criteria:

- Be healthy, free-living adults

- Be a non-smoker (defined as adults who have never smoked or who have not had a
cigarette in the past ten years)

- Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition
and alternative supplements for the duration of the study

- Agree to follow a berry-restricted diet and to document any accidental consumption of
restricted foods each day of the study

- Agree to abstain from mouthwashes

Exclusion Criteria:

- Have an active metabolic or digestive illness including malabsorptive disorders, renal
insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome

- Have an active or a recent history of any condition that causes altered immunity such
as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood
dyscrasias

- Have a known allergy or food intolerance to ingredients in study products (black
raspberries),other berries, wheat, or soy

- Are strict vegans (no consumption of animal, fish or egg products)

- Are planning to conceive, or are currently pregnant or lactating

- Are heavy alcohol consumers (defined as an average consumption of greater than 2
drinks/day)

- Have a history of oral cancer or currently undergoing treatment of oral cancer

- In the last month have had any active oral lesions or maladies or currently have any
oral disease or obvious open sores in the oral cavity or surrounding the oral opening

- Have strong gag reflex or problems swallowing that prohibit buccal brushing of the
oral cavity

- Have been on an antibiotic regime lasting for one week in the last 6 months