Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 04/30/2020 |
| Първо изпратено: | 02/10/2020 |
| Очаквано записване подадено: | 02/10/2020 |
| Първо публикувано: | 02/12/2020 |
| Изпратена последна актуализация: | 05/12/2020 |
| Последна актуализация публикувана: | 05/13/2020 |
| Действителна начална дата на проучването: | 10/24/2019 |
| Приблизителна дата на първично завършване: | 12/30/2022 |
| Очаквана дата на завършване на проучването: | 12/30/2022 |
Състояние или заболяване
Интервенция / лечение
Procedure: Biospecimen Collection
Dietary Supplement: Nutritional Supplementation
Drug: Placebo Administration
Other: Questionnaire Administration
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: 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. | |
| Experimental: 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. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 55 Years Да се 55 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Recruitment rates [Up to 3 years]
2. Study adherence [Up to 3 years]
3. Inflammatory markers found in nasal brushings [Up to 3 years]
4. Changes in stool microbe relative abundances [Up to 3 years]
5. Biologic responses to the black raspberry (BRB) nectar [Up to 3 years]
