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

NCT02439255 | Completed DMC

• 3 other identifiers: OSU-14135NCI-2014-02622P30CA016058
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to up to 12 weeks

Secondary Outcomes (2)

• Food frequency (FF) using the Viocare FF Questionnaire

  Week 0

• Gene expression levels using next generation sequencing (NGS)

  Up to 12 weeks

Study Arms (2)

Arm I Black raspberry(BRB) nectar

EXPERIMENTAL

Participants receive BRB nectar PO QD for 12 weeks.

Other: Laboratory Biomarker Analysis; Dietary Supplement: Phytochemical; Other: Screening Questionnaire Administration

Arm II (placebo nectar)

PLACEBO COMPARATOR

Participants receive placebo nectar PO QD for 12 weeks.

Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Screening Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I Black raspberry(BRB) nectar; Arm II (placebo nectar)

Phytochemical DIETARY_SUPPLEMENT

Given black raspberry (BRB) nectar per oral (PO)

Also known as: Phytonutrients

Arm I Black raspberry(BRB) nectar

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo nectar)

Screening Questionnaire Administration OTHER

Ancillary studies

Arm I Black raspberry(BRB) nectar; Arm II (placebo nectar)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Phytochemicals

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Purnima Kumar, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: December 4, 2015
• Primary Completion: June 30, 2018
• Study Completion: April 30, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)