Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial (BENEFIT)
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ClinicalTrials.gov Identifier: NCT01929122 |
Recruitment Status :
Completed
First Posted : August 27, 2013
Last Update Posted : July 21, 2017
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer Control and Prevention | Dietary Supplement: Placebo-Control Meals and Snacks Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks Dietary Supplement: Rice Bran Meals and Snacks | Not Applicable |
Objectives:
- 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.
- To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
- To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
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Placebo Comparator: 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.
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Dietary Supplement: Placebo-Control Meals and Snacks
Other Name: Whole food dietary intervention |
Experimental: 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.
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Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks
Other Name: Whole food dietary intervention |
Experimental: Rice Bran
Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.
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Dietary Supplement: Rice Bran Meals and Snacks
Other Name: Whole food dietary intervention |
- Stool Microbiome Composition and Metabolome [ Time Frame: 5 years ]
- Navy Bean or Rice Bran metabolites in stool, urine and blood. [ Time Frame: 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929122
United States, Colorado | |
Colorado State University | |
Fort Collins, Colorado, United States, 80523 | |
Poudre Valley Hospital Oncology Research | |
Fort Collins, Colorado, United States, 80528 |
Principal Investigator: | Elizabeth P Ryan, PhD | Colorado State University |
Publications of Results:
Responsible Party: | Elizabeth P Ryan, Assistant Professor of Toxicology and Nutrition, Colorado State University |
ClinicalTrials.gov Identifier: | NCT01929122 |
Other Study ID Numbers: |
10-1038 1R21CA161472-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | August 27, 2013 Key Record Dates |
Last Update Posted: | July 21, 2017 |
Last Verified: | July 2017 |
Prevention & control Diet Functional food Nutrition Assessment Oryza sativa Rice Bran |
Phaseolus vulgaris L. Legumes Microbiome Metabolomics Prebiotics |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |