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Trial record 42 of 2060 for:    Oral Cancer | NIH

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Purnima Kumar, Ohio State University Comprehensive Cancer Center

May 6, 2015
May 8, 2015
November 9, 2017
June 2014
February 1, 2018   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02439255 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Healthy Subject
  • Tobacco Use Disorder
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Dietary Supplement: Phytochemical
    Given BRB nectar PO
    Other Name: Phytonutrients
  • Other: Placebo
    Given PO
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
  • Other: Screening Questionnaire Administration
    Ancillary studies
  • Experimental: Arm I (BRB nectar)
    Participants receive BRB nectar PO QD for 12 weeks.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Dietary Supplement: Phytochemical
    • Other: Screening Questionnaire Administration
  • Placebo Comparator: Arm II (placebo nectar)
    Participants receive placebo nectar PO QD for 12 weeks.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Other: Placebo
    • Other: Screening Questionnaire Administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Same as current
August 1, 2019
February 1, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be periodontally healthy; this is defined as all sites with attachment levels =< 2 mm and probing depths =< 3 mm) and caries-free, as evidenced by a DMF (decayed, missing, filled teeth) Index of less than 5
  • Subject must be either a current smoker or a never smoker; to define a smoker, we will utilize the Centers for Disease Control definitions; any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker; smoking status will be assessed by a questionnaire; since only current and never smokers are included, it is not necessary to measure cotinine levels; the number of cigarettes smoked per day and years of smoking will be used to calculate pack-years, which will be used as a measure of tobacco exposure; a never smoker is defined as a person who never smoked, or smoked less than 100 cigarettes in their lifetime, and who has not had a cigarette in over ten years
  • Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study
  • Agree to follow a controlled ellagitannin/low polyphenolic diet and to document consumption of polyphenolic foods each day of the study using our easy to document daily form

Exclusion Criteria:

  • Have history of oral cancer or carcinoma in-situ
  • Have had antibiotic therapy or professional cleaning within the previous 3 months
  • Require antibiotic therapy prior to oral cleaning
  • Have an active metabolic or digestive illness that impact phytochemical absorption and metabolism, including: diabetes, malabsorptive disorders (Crohn's disease, documented celiac disease, etc.), renal insufficiency (creatinine [Cr] > 1.4), hepatic insufficiency (nonalcoholic steatohepatitis [NASH], cirrhosis, active viral hepatitis), hyper- or hypothyroidism, or short bowel syndrome
  • Are alcohol consumers (defined as an average consumption of greater than 1 drink/day over one week [wk] [one drink = 1 oz. liquor, 12 oz. beer])
  • Are taking immunosuppressant medications, bisphosphonates or steroid medications
  • Currently undergoing treatment for cancer with chemotherapy, hormone therapy, radiation, or biological therapy
  • Have a known allergy or food intolerance to ingredients in study products (black raspberries or other berries)
  • Are planning to conceive, or are currently pregnant or lactating
  • Have had any active oral lesions in the past month or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening
  • Are taking any medications that have known impact on immune responses (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] for chronic pain) or are actively being investigated for the prevention of tobacco related cancers will not be acceptable; a single 81 mg aspirin per day will be acceptable
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
United States
 
 
NCT02439255
OSU-14135
NCI-2014-02622 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Purnima Kumar, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Purnima Kumar Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP