This trial studies how well black raspberry nectar works in changing the gut microbiome and in reducing inflammatory processes that may lead to lung cancer. Studying the effects of black raspberry beverage on inflammation may help doctors find strategies to reduce the risk of developing lung cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
96
Undergo collection of nasal swabs, blood, urine, and stool
Given black raspberry nectar PO
Given PO
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruitment rates
Recruitment rates will be defined as the proportion of screened accrued relative to those approached. Successful recruitment rates will be defined as \>= 10% of participants approached agree to participate.
Time frame: Up to 3 years
Study adherence
Study adherence will be defined as the percent of the biospecimens collected at the end of the study period, with a compliance goal of 60%. Will track the monthly collection of data and document reasons for missing any scheduled collection dates. The proportions of missing information at each time point will be calculated. Descriptive statistics will examine the distribution of all patient and treatment characteristics, overall and by patient and disease characteristics.
Time frame: Up to 3 years
Inflammatory markers found in nasal brushings
Evaluated by ribonucleic acid sequencing.
Time frame: Up to 3 years
Changes in stool microbe relative abundances
Evaluated by metagenomic whole sequencing.
Time frame: Up to 3 years
Biologic responses to the black raspberry (BRB) nectar
Samples of urine, stool. and blood will be analyzed for BRB phytochemicals (ellagitannins, ellagic acid, quercetin glycosides, anthocyanins) and their metabolites (urolithins, quercetin glucuronides/sulfates, methylated anthocyanins).
Time frame: Up to 3 years
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