Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 240
Summary
- Conditions
- Healthy Subject
- Tobacco Use Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
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 p...
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.
Tracking Information
- NCT #
- NCT02439255
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Purnima Kumar Ohio State University Comprehensive Cancer Center
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