Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 1, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Early Phase 1
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Interventions being studied
- Procedure: Biospecimen Collection; Dietary Supplement: Nutritional Supplementation; Drug: Placebo Administration; Other: Questionnaire Administration
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 1, 2023. Always confirm current availability with the study team.