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

NCT ID: NCT02439255

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-04
• Study Completion Date: 2022-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm I Black raspberry(BRB) nectar

Participants receive BRB nectar PO QD for 12 weeks.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Phytochemical

Intervention Type: DIETARY_SUPPLEMENT

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

Screening Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (placebo nectar)

Participants receive placebo nectar PO QD for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Placebo

Intervention Type: OTHER

Given PO

Screening Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Phytochemical

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Given PO

Intervention Type: OTHER

Screening Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Phytonutrients; placebo therapy; PLCB; sham therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Purnima Kumar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Purnima Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2014-02622

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA016058

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-14135

Identifier Type: -

Identifier Source: org_study_id