Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatments fast release brb confection, intermed release brbconfect, prolong release brb confect
Phase phase 1
Sponsor Ohio State University Comprehensive Cancer Center
Start date July 2013
End date December 2016
Trial size 60 participants
Trial identifier NCT01961869, NCI-2013-01724, OSU-13052

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.
fast release brb confection black raspberry confection
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
(Experimental)
Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
fast release brb confection black raspberry confection
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
(Experimental)
Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
intermed release brbconfect black raspberry confection
Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
(Experimental)
Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
intermed release brbconfect black raspberry confection
Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
(Experimental)
Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
prolong release brb confect black raspberry confection
Prolonged release BRB confection includes lyophilized black raspberry powder, corn syrup, corn starch, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients.
(Experimental)
Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
prolong release brb confect black raspberry confection
Prolonged release BRB confection includes lyophilized black raspberry powder, corn syrup, corn starch, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients.

Primary Outcomes

Measure
Acceptance of candidate formulations, assessed using a 9 point hedonic scale (1 =dislike very much, 9 = like very much)
time frame: Up to day 14
Bioavailability index, defined as the average rank of BRB effect in anthocyanins, ellagic acid, urolithins, and quercetin derivatives
time frame: Up to day 14
Gene expression index, defined as the average rank of BRB effect on expression of genes responsive to BRBs and important to smoking and inflammatory response
time frame: Up to day 14

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis
Principal investigator Yael Vodovotz, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.