Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

The Ohio State University

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Prolong release BRB confection; Other: Intermed release BRB confection; Other: Fast release BRB confection

Study type: Interventional

Funder types: Other

Identifiers

NCT01961869

OSU-13052

NCI-2013-01724 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 6 patient groups

Arm I (Fast release BRB confection 4g)

Experimental group

Description:

Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.

Treatment:

Other: Fast release BRB confection

Arm II (Fast release BRB confection 8g)

Experimental group

Description:

Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.

Treatment:

Other: Fast release BRB confection

Arm III (Intermed release BRBconfection 4g)

Experimental group

Description:

Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.

Treatment:

Other: Intermed release BRB confection

Arm IV (Intermed release BRBconfection 8g)

Experimental group

Description:

Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.

Treatment:

Other: Intermed release BRB confection

Arm V (Prolong release BRB confection 4g)

Experimental group

Description:

Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.

Treatment:

Other: Prolong release BRB confection

Arm VI (Prolong release BRB confection 8g)

Experimental group

Description:

Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.

Treatment:

Other: Prolong release BRB confection