Healthy SubjectNCT02439255
Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers
A study testing Laboratory Biomarker Analysis, Phytochemical and Screening Questionnaire Administration in people with Healthy Subject and Tobacco Use Disorder, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies the effects of black raspberry compounds (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and non-smokers. The oral microbiome protects the body from pathogenic bacteria. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Tobacco Use Disorder
- What is being tested?
- Laboratory Biomarker Analysis, Phytochemical and Screening Questionnaire Administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2015to 30 Apr 2022
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be periodontally healthy; this is defined as all sites with attachment levels =< 2 mm and probing depths =< 3 mm) and caries-free, as evidenced by a DMF (decayed, missing, filled teeth) Index of less than 5
- Subject must be either a current smoker or a never smoker; to define a smoker, we will utilize the Centers for Disease Control definitions; any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker; smoking status will be assessed by a questionnaire; since only current and never smokers are included, it is not necessary to measure cotinine levels; the number of cigarettes smoked per day and years of smoking will be used to calculate pack-years, which will be used as a measure of tobacco exposure; a never smoker is defined as a person who never smoked, or smoked less than 100 cigarettes in their lifetime, and who has not had a cigarette in over ten years
- Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study
- Agree to follow a controlled ellagitannin/low polyphenolic diet and to document consumption of polyphenolic foods each day of the study using our easy to document daily form
Who cannot join
- Have history of oral cancer or carcinoma in-situ
- Have had antibiotic therapy or professional cleaning within the previous 3 months
- Require antibiotic therapy prior to oral cleaning
- Have an active metabolic or digestive illness that impact phytochemical absorption and metabolism, including: diabetes, malabsorptive disorders (Crohn's disease, documented celiac disease, etc.), renal insufficiency (creatinine [Cr] > 1.4), hepatic insufficiency (nonalcoholic steatohepatitis [NASH], cirrhosis, active viral hepatitis), hyper- or hypothyroidism, or short bowel syndrome
- Are alcohol consumers (defined as an average consumption of greater than 1 drink/day over one week [wk] [one drink = 1 oz. liquor, 12 oz. beer])
- Are taking immunosuppressant medications, bisphosphonates or steroid medications
Show all 11Show fewer
- Currently undergoing treatment for cancer with chemotherapy, hormone therapy, radiation, or biological therapy
- Have a known allergy or food intolerance to ingredients in study products (black raspberries or other berries)
- Are planning to conceive, or are currently pregnant or lactating
- Have had any active oral lesions in the past month or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening
- Are taking any medications that have known impact on immune responses (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] for chronic pain) or are actively being investigated for the prevention of tobacco related cancers will not be acceptable; a single 81 mg aspirin per day will be acceptable
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
About this study
Official title: Interactive Omics: Black Raspberry Metabolites and the Oral Microbiome in Smokers
This randomized clinical trial studies the effects of black raspberry compounds (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and non-smokers. The oral microbiome protects the body from pathogenic bacteria. Smoking alters the oral microbiome and may increase the susceptibility to cancer by modulating normal host-bacteria interactions. Black raspberry phytochemicals may protect the oral microbiome of smokers and may lower their risk of developing oral cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the effect of black raspberry phytochemicals on community dynamics within oral biofilms.
II. Examine the effect of oral bacterial communities on metabolism of black raspberry phytochemicals in current and never smokers.
III. Evaluate the efficacy of black raspberry phytochemicals and their metabolites in reversing the effect of smoking on oral host-microbial interactions.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive bioactivity of black raspberry phytochemical-rich delivery vehicle (BRB nectar) orally (PO) once daily (QD) for 12 weeks.
ARM II: Participants receive placebo nectar PO QD for 12 weeks.
- Conditions
- Healthy Subject, Tobacco Use Disorder
- Being tested
- Laboratory Biomarker Analysis, Phytochemical, Placebo, Screening Questionnaire Administration
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
PhytochemicalDietary supplement
Also called Phytonutrients
Given black raspberry (BRB) nectar per oral (PO)
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Screening Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I Black raspberry(BRB) nectar | Experimental | Participants receive BRB nectar PO QD for 12 weeks. Receives: Other: Laboratory Biomarker Analysis; Dietary Supplement: Phytochemical; Other: Screening Questionnaire Administration |
| Arm II (placebo nectar) | Placebo comparator | Participants receive placebo nectar PO QD for 12 weeks. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Screening Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the microbial shift
The analyses of the microbial shift data will use a two-factor (smoking and berry treatment) ANOVA model with interaction on the post-treatment minus baseline differences between appropriately transformed data. Phylogenetic distances and community similarity and diversity will be computed from the sequence data. The sensitivity of the phylogenetic analysis to the uncertain knowledge of the phylogenetic relationships will be examined using draws from the posterior distribution of trees in a Mr. Bayes analysis.
Measured: Baseline to 12 weeks
Change of metabolite profile in saliva, urine, and blood using high-performance liquid chromatography-mass spectrometry
The analyses of the metabolite endpoint will use a two-factor (smoking and berry treatment) analysis of variance (ANOVA) model with interaction on the post-treatment minus baseline differences between appropriately transformed data. The number of transcripts as well as the level of each transcript (transformed values) will be used to compute a Bray-Curtis similarity Index between the community profile post-treatment and the baseline profile.
Measured: Baseline to up to 12 weeks
Secondary outcomes (2)
Food frequency (FF) using the Viocare FF Questionnaire
PROC MIXED repeated measures models will be used.
Measured: Week 0
Gene expression levels using next generation sequencing (NGS)
The presence and abundance of mucosal messenger ribonucleic acid transcripts will be computed from the NGD sequence data. Variance stabilizing transformation will be applied to gene expression levels. The significance of differences between the two groups over time is then studied as changes in this contrast for smokers versus non-smokers.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start4 Dec 2015
- Primary completion30 Jun 2018
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Purnima Kumar, Ohio State University Comprehensive Cancer Center
- Investigators
- Purnima Kumar, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439255
- Sponsor's protocol ID
- OSU-14135
- Other IDs
- NCI-2014-02622, P30CA016058
- Status last verified
- Oct 2022
- First submitted
- 6 May 2015
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Omics: Black Raspberry Metabolites and the Oral Microbiome in Smokers
- ClinicalTrials.gov ID
- NCT02439255
- Acronym / sponsor ID
- OSU-14135
- Conditions
- Healthy Subject, Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies the effects of black raspberry compounds (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and non-smokers. The oral microbiome protects the body from pathogenic bacteria. Smoking alters the oral microbiome and may increase the susceptibility to cancer by modulating normal host-bacteria interactions. Black raspberry phytochemicals may protect the oral microbiome of smokers and may lower their risk of developing oral cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine the effect of black raspberry phytochemicals on community dynamics within oral biofilms.
II. Examine the effect of oral bacterial communities on metabolism of black raspberry phytochemicals in current and never smokers.
III. Evaluate the efficacy of black raspberry phytochemicals and their metabolites in reversing the effect of smoking on oral host-microbial interactions.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive bioactivity of black raspberry phytochemical-rich delivery vehicle (BRB nectar) orally (PO) once daily (QD) for 12 weeks.
ARM II: Participants receive placebo nectar PO QD for 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I Black raspberry(BRB) nectar | Experimental | Other: Laboratory Biomarker Analysis, Dietary Supplement: Phytochemical, Other: Screening Questionnaire AdministrationParticipants receive BRB nectar PO QD for 12 weeks. |
| Arm II (placebo nectar) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: Placebo, Other: Screening Questionnaire AdministrationParticipants receive placebo nectar PO QD for 12 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects must be periodontally healthy; this is defined as all sites with attachment levels =< 2 mm and probing depths =< 3 mm) and caries-free, as evidenced by a DMF (decayed, missing, filled teeth) Index of less than 5
- Subject must be either a current smoker or a never smoker; to define a smoker, we will utilize the Centers for Disease Control definitions; any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker; smoking status will be assessed by a questionnaire; since only current and never smokers are included, it is not necessary to measure cotinine levels; the number of cigarettes smoked per day and years of smoking will be used to calculate pack-years, which will be used as a measure of tobacco exposure; a never smoker is defined as a person who never smoked, or smoked less than 100 cigarettes in their lifetime, and who has not had a cigarette in over ten years
- Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study
- Agree to follow a controlled ellagitannin/low polyphenolic diet and to document consumption of polyphenolic foods each day of the study using our easy to document daily form
Key exclusion criteria (11 listed)
- Have history of oral cancer or carcinoma in-situ
- Have had antibiotic therapy or professional cleaning within the previous 3 months
- Require antibiotic therapy prior to oral cleaning
- Have an active metabolic or digestive illness that impact phytochemical absorption and metabolism, including: diabetes, malabsorptive disorders (Crohn's disease, documented celiac disease, etc.), renal insufficiency (creatinine [Cr] > 1.4), hepatic insufficiency (nonalcoholic steatohepatitis [NASH], cirrhosis, active viral hepatitis), hyper- or hypothyroidism, or short bowel syndrome
- Are alcohol consumers (defined as an average consumption of greater than 1 drink/day over one week [wk] [one drink = 1 oz. liquor, 12 oz. beer])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I Black raspberry(BRB) nectar, Arm II (placebo nectar) |
| PhytochemicalAlso: PhytonutrientsGiven black raspberry (BRB) nectar per oral (PO) | Dietary supplement | Arm I Black raspberry(BRB) nectar |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (placebo nectar) |
| Screening Questionnaire AdministrationAncillary studies | Other | Arm I Black raspberry(BRB) nectar, Arm II (placebo nectar) |
Primary outcome
Change in the microbial shift
Time frame: Baseline to 12 weeks
The analyses of the microbial shift data will use a two-factor (smoking and berry treatment) ANOVA model with interaction on the post-treatment minus baseline differences between appropriately transformed data. Phylogenetic distances and community similarity and diversity will be computed from the sequence data. The sensitivity of the phylogenetic analysis to the uncertain knowledge of the phylogenetic relationships will be examined using draws from the posterior distribution of trees in a Mr. Bayes analysis.
Change of metabolite profile in saliva, urine, and blood using high-performance liquid chromatography-mass spectrometry
Time frame: Baseline to up to 12 weeks
The analyses of the metabolite endpoint will use a two-factor (smoking and berry treatment) analysis of variance (ANOVA) model with interaction on the post-treatment minus baseline differences between appropriately transformed data. The number of transcripts as well as the level of each transcript (transformed values) will be used to compute a Bray-Curtis similarity Index between the community profile post-treatment and the baseline profile.
2 secondary outcomes
Food frequency (FF) using the Viocare FF Questionnaire
Time frame: Week 0
Gene expression levels using next generation sequencing (NGS)
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purnima Kumar, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Phytochemical and Screening Questionnaire Administration in people with Healthy Subject and Tobacco Use Disorder, 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 4 inclusion and 11 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 5 Oct 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in the microbial shift (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2022.