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Completed

NCT Number: NCT01961869

Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: black raspberry confection, BRB confection, LBR lozenge

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

Other names: black raspberry confection, BRB confection, LBR lozenge

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.

Other names: black raspberry confection, BRB confection, LBR lozenge

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 14, 2013
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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