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Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01961869
Recruitment Status : Active, not recruiting
First Posted : October 14, 2013
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Yael Vodovotz, Ohio State University Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Fast release BRB confection Other: Intermed release BRB confection Other: Prolong release BRB confection Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 BRBconfection 4g)
Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Other: Intermed release BRB 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
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm IV (Intermed release BRBconfection 8g)
Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Other: Intermed release BRB 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
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm V (Prolong release BRB confection 4g)
Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Other: Prolong release BRB 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.
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge
Experimental: Arm VI (Prolong release BRB confection 8g)
Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Other: Prolong release BRB 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.
Other Names:
  • black raspberry confection
  • BRB confection
  • LBR lozenge



Primary Outcome Measures :
  1. 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 ]
    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.

  2. Bioavailability index, defined as the average rank of BRB effect in anthocyanins, ellagic acid, urolithins, and quercetin derivatives [ Time Frame: Up to day 14 ]
    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).

  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 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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