Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
NCT ID: NCT04267874
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
96 participants
INTERVENTIONAL
2019-10-25
2021-06-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Arm I (BRB nectar, placebo, biospecimen collection)
Patients receive BRB nectar PO 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.
Biospecimen Collection
Undergo collection of nasal swabs, blood, urine, and stool
Nutritional Supplementation
Given black raspberry nectar PO
Placebo Administration
Given PO
Questionnaire Administration
Ancillary studies
Arm II (placebo, BRB nectar, biospecimen collection)
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.
Biospecimen Collection
Undergo collection of nasal swabs, blood, urine, and stool
Nutritional Supplementation
Given black raspberry nectar PO
Placebo Administration
Given PO
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of nasal swabs, blood, urine, and stool
Nutritional Supplementation
Given black raspberry nectar PO
Placebo Administration
Given PO
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
55 Years
77 Years
ALL
Yes
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Daniel Spakowicz
Principal Investigator
Principal Investigators
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Daniel Spakowicz, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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The Jamesline
Other Identifiers
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NCI-2020-00418
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-19007
Identifier Type: -
Identifier Source: org_study_id