Clinical trial · Interventional
Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
The BE WELL Study: Black Raspberry Beverage Working to Prevent Lung Cancer
NCT04267874CI-TRIAL-00071904completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tobacco-Related Carcinoma | Tobacco-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Nutritional Supplementation | Dietary Supplement | — | UNRESOLVED |
| Placebo Administration | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (BRB nectar, placebo, biospecimen collection)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Dietary Supplement: Nutritional Supplementation
- Drug: Placebo Administration
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (placebo, BRB nectar, biospecimen collection)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.