Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study

PRIMARY FEASIBILITY OBJECTIVE:

I. To evaluate the feasibility of establishing a diet intervention trial with longitudinal microbiome collection in Ohio State University Comprehensive Cancer Center (OSUCCC) Lung Cancer Screening Clinic (OSUCCC-LCSC).

PRIMARY SCIENTIFIC OBJECTIVE:

I. To determine the impact of the black raspberry (BRB) nectar intervention on the microbiome and inflammatory biomarkers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive BRB nectar orally (PO) twice daily (BID) for weeks 0-4 and then receive placebo PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

ARM II: Patients receive placebo PO BID for weeks 0-4 and then receive BRB nectar PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

Inclusion criteria

• Have a 30 pack-year smoking history
• Be either a current smoker or a former smoker that quit in the last 15 years. Any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker
• Agree to consume a standardized vitamin / mineral supplement and avoid other nutritional, dietary or alternative medications / supplements / probiotics for the duration of the study
• Agree to follow a berry-free / controlled phenolic diet and to document consumption of polyphenolic foods each day of the study using a simple daily form

Exclusion criteria

• Person has an allergy to any berries, pectin, or food colorants apples,as well as kiwi fruit, strawberries, soy sauce, pine nuts, almonds, cherries, peaches, blackberries, pears
• Person states that they are not a:

• Current smoker: active cigarette smoker who has smoked more than 30 pack-years in the last 15 years OR
• Former smoker: not a current smoker active cigarette smoker who has smoked more than 30 pack years in the last 15 years
• Person is unwilling to follow a berry-free/controlled polyphenol diet while on study
• Person has history of metabolic disorders (diabetes, hyper/hypo-thyroidism, etc.); digestive illness which may result in nutrient malabsorption (Crohn's disease, Celiac, renal/hepatic insufficiency, short bowel, etc.); disorders that affect connective tissues; or blood clotting disorders
• Person has allergy or food intolerance to ingredients in study products (black raspberries or other berries)
• Person is on a regimen of any of the following medications:

• Immunosuppressants, bisphosphonates, or steroids.
• Anticoagulants (warfarin, apixaban, dabigatran, and rivaroxaban)
• Probiotics
• Person is undergoing treatment for cancer in any form
• Person is currently pregnant or nursing or plans to become pregnant during this study
• Person plans to enter smoking cessation or change their smoking status during the course of the study