Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers

NCT02439255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2022-10-05

No results posted yet for this study

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.

Conditions

  • Healthy Subject
  • Tobacco Use Disorder

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Purnima Kumar, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-04
Primary Completion
2018-06-30
Completion
2022-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439255 on ClinicalTrials.gov