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Trial record 83 of 11725 for:    Oral Cancer

Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01961869
Recruitment Status : Active, not recruiting
First Posted : October 14, 2013
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yael Vodovotz, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE October 10, 2013
First Posted Date  ICMJE October 14, 2013
Last Update Posted Date March 19, 2019
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2013)
  • 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.
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01961869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers
Official Title  ICMJE Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Fast release BRB confection
  • 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.
    Intervention: Other: Fast release BRB confection
  • Experimental: Arm III (Intermed release BRBconfection 4g)
    Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
    Intervention: Other: Intermed release BRB confection
  • Experimental: Arm IV (Intermed release BRBconfection 8g)
    Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
    Intervention: Other: Intermed release BRB confection
  • 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.
    Intervention: Other: Prolong release BRB confection
  • 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.
    Intervention: Other: Prolong release BRB confection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01961869
Other Study ID Numbers  ICMJE OSU-13052
NCI-2013-01724 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yael Vodovotz, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yael Vodovotz, Ph.D. Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP