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Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial (BENEFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929122
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Poudre Valley Health System
Information provided by (Responsible Party):
Elizabeth P Ryan, Colorado State University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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

Detailed Description:

Objectives:

  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.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 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.
 Dietary Supplement: Rice Bran Meals and Snacks
Other Name: Whole food dietary intervention


Outcome Measures
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Primary Outcome Measures :
  1. Stool Microbiome Composition and Metabolome [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Navy Bean or Rice Bran metabolites in stool, urine and blood. [ Time Frame: 5 years ]

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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Colorado
Colorado State University
Fort Collins, Colorado, United States, 80523
Poudre Valley Hospital Oncology Research
Fort Collins, Colorado, United States, 80528
Sponsors and Collaborators
Colorado State University
National Cancer Institute (NCI)
Poudre Valley Health System
Investigators
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Principal Investigator: Elizabeth P Ryan, PhD Colorado State University
More Information
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Additional Information:

Publications of Results:

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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
Keywords provided by Elizabeth P Ryan, Colorado State University:
Prevention & control
Diet
Functional food
Nutrition Assessment
Oryza sativa
Rice Bran
 Phaseolus vulgaris L.
Legumes
Microbiome
Metabolomics
Prebiotics
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases