Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis

This clinical trial studies black raspberry confection in preventing oral cancer in healthy volunteers. Black raspberry contains ingredients that may prevent or slow the growth of certain cancers.

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