Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers
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|ClinicalTrials.gov Identifier: NCT02439255|
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment|
|Healthy Subject Tobacco Use Disorder||Other: Laboratory Biomarker Analysis Dietary Supplement: Phytochemical Other: Placebo Other: Screening Questionnaire Administration|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interactive Omics: Black Raspberry Metabolites and the Oral Microbiome in Smokers|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||February 1, 2018|
|Estimated Study Completion Date :||August 1, 2019|
Experimental: Arm I (BRB nectar)
Participants receive BRB nectar PO QD for 12 weeks.
Other: Laboratory Biomarker Analysis
Correlative studiesDietary Supplement: Phytochemical
Given BRB nectar PO
Other Name: PhytonutrientsOther: Screening Questionnaire Administration
Placebo Comparator: Arm II (placebo nectar)
Participants receive placebo nectar PO QD for 12 weeks.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Placebo
Other Names:Other: Screening Questionnaire Administration
- 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. Unifrac distances and community similarity and diversity will be computed from the sequence data. The sensitivity of the Unifrac 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.
- Food frequency (FF) using the Viocare FF Questionnaire [ Time Frame: Week 0 ]PROC MIXED repeated measures models will be used.
- Gene expression levels using next generation sequencing (NGS) [ Time Frame: Up to 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439255
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Purnima Kumar 614-247-4532 firstname.lastname@example.org|
|Principal Investigator: Purnima Kumar|
|Principal Investigator:||Purnima Kumar||Ohio State University Comprehensive Cancer Center|