- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02439255
Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers
Interactive Omics: Black Raspberry Metabolites and the Oral Microbiome in Smokers
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I Black raspberry(BRB) nectar
Participants receive BRB nectar PO QD for 12 weeks.
|
Correlative studies
Given black raspberry (BRB) nectar per oral (PO)
Other Names:
Ancillary studies
|
Placebo Comparator: Arm II (placebo nectar)
Participants receive placebo nectar PO QD for 12 weeks.
|
Correlative studies
Given PO
Other Names:
Ancillary studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline to 12 weeks
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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.
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Baseline to up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food frequency (FF) using the Viocare FF Questionnaire
Time Frame: Week 0
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PROC MIXED repeated measures models will be used.
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Week 0
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Gene expression levels using next generation sequencing (NGS)
Time Frame: Up to 12 weeks
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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.
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Up to 12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Purnima Kumar, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-14135
- P30CA016058 (U.S. NIH Grant/Contract)
- NCI-2014-02622 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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