Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study (NCT04267874) | Clinical Trial Compass
CompletedEarly Phase 1
Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
United States96 participantsStarted 2019-10-25
Plain-language summary
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.
Who can participate
Age range55 Years – 77 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 intole…
What they're measuring
1
Recruitment rates
Timeframe: Up to 3 years
2
Study adherence
Timeframe: Up to 3 years
3
Inflammatory markers found in nasal brushings
Timeframe: Up to 3 years
4
Changes in stool microbe relative abundances
Timeframe: Up to 3 years
5
Biologic responses to the black raspberry (BRB) nectar
Timeframe: Up to 3 years
Trial details
NCT IDNCT04267874
SponsorOhio State University Comprehensive Cancer Center