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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
148
Correlative studies
Given black raspberry (BRB) nectar per oral (PO)
Given PO
Ancillary studies
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
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.
Time frame: 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.
Time frame: Baseline to up to 12 weeks
Food frequency (FF) using the Viocare FF Questionnaire
PROC MIXED repeated measures models will be used.
Time frame: 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.
Time frame: Up to 12 weeks
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