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Healthy VolunteersPhase 1NCT01961869

Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

A Phase 1 study testing Fast release BRB confection, Intermed release BRB confection and Prolong release BRB confection in people with Healthy Volunteers, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Fast release BRB confection, Intermed release BRB confection and Prolong release BRB confection
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteUnited States
Study dates
2 Jul 2013to 14 May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Fast release BRB confection, Intermed release BRB confection, Prolong release BRB confection
Keywords
black raspberry, chemoprevention, oral delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fast release BRB confectionOther

    Also called black raspberry confection, BRB confection, LBR lozenge

    Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients

  • Intermed release BRB confectionOther

    Also called black raspberry confection, BRB confection, LBR lozenge

    Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients

  • Prolong release BRB confectionOther

    Also called black raspberry confection, BRB confection, LBR lozenge

    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.

Study groups in NCT01961869
Study groupRoleWhat they receive
Arm I (Fast release BRB confection 4g)ExperimentalParticipants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.
Receives: Other: Fast release BRB confection
Arm II (Fast release BRB confection 8g)ExperimentalParticipants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Receives: Other: Fast release BRB confection
Arm III (Intermed release BRBconfection 4g)ExperimentalParticipants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Receives: Other: Intermed release BRB confection
Arm IV (Intermed release BRBconfection 8g)ExperimentalParticipants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Receives: Other: Intermed release BRB confection
Arm V (Prolong release BRB confection 4g)ExperimentalParticipants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Receives: Other: Prolong release BRB confection
Arm VI (Prolong release BRB confection 8g)ExperimentalParticipants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Receives: Other: Prolong release BRB confection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to day 14

  2. 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).

    Measured: Up to day 14

  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

    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).

    Measured: Up to day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2013 (estimated)
  2. Study start2 Jul 2013
  3. Primary completion14 May 2014
  4. Study completion14 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01961869
Sponsor's protocol ID
OSU-13052
Other IDs
NCI-2013-01724
Status last verified
Jun 2026
First submitted
10 Oct 2013
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fast release BRB confection, Intermed release BRB confection and Prolong release BRB confection in people with Healthy Volunteers, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01961869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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