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

This is an interventional prevention trial for Healthy Subject Read More

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