Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
NCT ID: NCT01929122
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2010-08-31
2014-12-31
Brief Summary
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Detailed Description
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1. To learn about how increased cooked navy bean powders or rice bran dietary intake affect the stool microbiota of colorectal cancer survivors and healthy adults.
2. To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
3. To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Placebo-Control
Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.
Placebo-Control Meals and Snacks
Cooked Navy Bean Powder
Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.
Cooked Navy Bean Powder Meals and Snacks
Rice Bran
Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.
Rice Bran Meals and Snacks
Interventions
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Placebo-Control Meals and Snacks
Cooked Navy Bean Powder Meals and Snacks
Rice Bran Meals and Snacks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Poudre Valley Health System
OTHER
Colorado State University
OTHER
Responsible Party
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Elizabeth P Ryan
Assistant Professor of Toxicology and Nutrition
Principal Investigators
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Elizabeth P Ryan, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado State University
Locations
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Colorado State University
Fort Collins, Colorado, United States
Poudre Valley Hospital Oncology Research
Fort Collins, Colorado, United States
Countries
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References
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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. doi: 10.2174/1573401310666140306005934.
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. 2016 Nov-Dec;68(8):1269-1280. doi: 10.1080/01635581.2016.1224370. Epub 2016 Sep 30.
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(1):10.1002/mnfr.201500905. doi: 10.1002/mnfr.201500905. Epub 2016 Sep 12.
Related Links
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Other Identifiers
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10-1038
Identifier Type: -
Identifier Source: org_study_id
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