Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yael Vodovotz, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01961869
First received: October 10, 2013
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Other: Fast release BRB confection
Other: Intermed release BRBconfect
Other: Prolong release BRB confect
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Compliance and safety of the confections will be evaluated using dietary and sensory questionnaires. The analysis of variance (ANOVA) style model accounting for the random effect of the individual subject and the fixed effect of the dissolution (amorphous confection form) group will be used to examine the effect of attribute data, gender, and age using a 9-point hedonic scale. The significant differences between means of the different groups will be examined using the Ryan-Einot-Gabriel-Welsch (REGW) multiple comparisons test.

  • Bioavailability index, defined as the average rank of BRB effect in anthocyanins, ellagic acid, urolithins, and quercetin derivatives [ Time Frame: Up to day 14 ] [ Designated as safety issue: No ]
    To select an optimal delivery vehicle & dose, a combination that results in any of 10 subjects having an adverse event will be eliminated in the 1st stage. In the 2nd and 3rd stages ANOVA style models accounting for the random effect of individual subject and the fixed effect of dose & release rate will be used to examine phytonutrient metabolite & gene expression. Using the multiple comparisons with the best procedure, any combination will be eliminated that is significantly worse than the best combination for a global index of bioavailability (stage 2) and gene expression effects (stage 3).

  • 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 ] [ Designated as safety issue: No ]
    To select an optimal delivery vehicle & dose, a combination that results in any of 10 subjects having an adverse event will be eliminated in the 1st stage. In the 2nd and 3rd stages ANOVA style models accounting for the random effect of individual subject and the fixed effect of dose & release rate will be used to examine phytonutrient metabolite & gene expression. Using the multiple comparisons with the best procedure, any combination will be eliminated that is significantly worse than the best combination for a global index of bioavailability (stage 2) and gene expression effects (stage 3).


Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (Fast release BRB confection 4g)
Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.
Other: Fast release BRB confection
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm II (Fast release BRB confection 8g)
Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Other: Fast release BRB confection
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm III (Intermed release BRBconfect 4g)
Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Other: Intermed release BRBconfect
Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm IV (Intermed release BRBconfect 8g)
Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Other: Intermed release BRBconfect
Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm V (Prolong release BRB confect 4g)
Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Other: Prolong release BRB confect
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.
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm VI (Prolong release BRB confect 8g)
Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Other: Prolong release BRB confect
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.
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961869

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Yael Vodovotz, Ph.D. Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Yael Vodovotz, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01961869     History of Changes
Other Study ID Numbers: OSU-13052, NCI-2013-01724
Study First Received: October 10, 2013
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
black raspberry
chemoprevention
oral delivery

ClinicalTrials.gov processed this record on July 23, 2014