Colorectal Cancer Control and Prevention Clinical Trial
— BENEFITOfficial title:
BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
| Verified date | July 2017 |
| Source | Colorado State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - = 18 years of age. - Be a Colorectal Cancer Survivor that is a minimum of 4 months post chemotherapy/radiation treatment. OR be a healthy adult with no prior history of treatment for cancer. - BMI between 25-35 - no previous or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease free for five years. - Ability to complete questionnaire(s) and dietary food logs - Willingness to consume meals/snacks provided for 28 consecutive days - Drink less than or equal to one alcoholic drink/day Exclusion Criteria: - History of food allergies and/or major dietary restrictions - Pregnant or lactating or planning to become pregnant - Self identified as a smoker - Taking prescribed medication to control their lipids - Taking Bean-O, other anti-flatulence medications or prolonged antibiotic use (one month) - Have a history of gallstones. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Colorado State University | Fort Collins | Colorado |
| United States | Poudre Valley Hospital Oncology Research | Fort Collins | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Colorado State University | National Cancer Institute (NCI), Poudre Valley Health System |
United States,
Borresen EC, Brown DG, Harbison G, Taylor L, Fairbanks A, O'Malia J, Bazan M, Rao S, Bailey SM, Wdowik M, Weir TL, Brown RJ, Ryan EP. A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. Nutr Cancer. — View Citation
Borresen EC, Gundlach KA, Wdowik M, Rao S, Brown RJ, Ryan EP. Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. Curr Nutr Food Sci. 2014 May;10(2):112-119. — View Citation
Sheflin AM, Borresen EC, Kirkwood JS, Boot CM, Whitney AK, Lu S, Brown RJ, Broeckling CD, Ryan EP, Weir TL. Dietary supplementation with rice bran or navy bean alters gut bacterial metabolism in colorectal cancer survivors. Mol Nutr Food Res. 2017 Jan;61( — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Stool Microbiome Composition and Metabolome | 5 years | ||
| Secondary | Navy Bean or Rice Bran metabolites in stool, urine and blood. | 5 years |