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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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. 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: 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.

Conditions

• Healthy Subject
• Tobacco Use Disorder

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIETARY_SUPPLEMENT	Phytochemical	Given black raspberry (BRB) nectar per oral (PO)
OTHER	Placebo	Given PO
OTHER	Screening Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-12-04
• Primary completion: 2018-06-30
• Completion: 2022-04-30
• First posted: 2015-05-08
• Last updated: 2022-10-05

Locations

1 site across 1 country: United States