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Completed
NCT01961869
Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 67
Sponsor: Ohio State University Comprehensive Cancer Center
Location: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT01961869). StuddyBuddy aggregates publicly available trial information.