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| ID | Type | Description | Link |
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| NCI-2013-01724 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Fast release BRB confection 4g) | Experimental | Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks. |
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| Arm II (Fast release BRB confection 8g) | Experimental | Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks. |
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| Arm III (Intermed release BRBconfection 4g) | Experimental | Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks. |
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| Arm IV (Intermed release BRBconfection 8g) | Experimental | Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks. |
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| Arm V (Prolong release BRB confection 4g) | Experimental | Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast release BRB confection | Other | Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of candidate formulations, assessed using a 9 point hedonic scale (1 =dislike very much, 9 = like very much) | 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. | Up to day 14 |
| Bioavailability index, defined as the average rank of BRB effect in anthocyanins, ellagic acid, urolithins, and quercetin derivatives | 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). | 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 | 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). | Up to day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yael Vodovotz, Ph.D. | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
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| The Jamesline | View source |
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| Arm VI (Prolong release BRB confection 8g) | Experimental | Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks. |
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| Intermed release BRB confection | Other | Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients |
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| Prolong release BRB confection | Other | 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. |
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