Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial (BENEFIT)
Primary Purpose
Colorectal Cancer Control and Prevention
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo-Control Meals and Snacks
Cooked Navy Bean Powder Meals and Snacks
Rice Bran Meals and Snacks
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer Control and Prevention focused on measuring Prevention & control, Diet, Functional food, Nutrition Assessment, Oryza sativa, Rice Bran, Phaseolus vulgaris L., Legumes, Microbiome, Metabolomics, Prebiotics
Eligibility 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.
Sites / Locations
- Colorado State University
- Poudre Valley Hospital Oncology Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo-Control
Cooked Navy Bean Powder
Rice Bran
Arm Description
Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.
Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.
Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.
Outcomes
Primary Outcome Measures
Stool Microbiome Composition and Metabolome
Secondary Outcome Measures
Navy Bean or Rice Bran metabolites in stool, urine and blood.
Full Information
NCT ID
NCT01929122
First Posted
August 22, 2013
Last Updated
July 18, 2017
Sponsor
Colorado State University
Collaborators
National Cancer Institute (NCI), Poudre Valley Health System
1. Study Identification
Unique Protocol Identification Number
NCT01929122
Brief Title
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
Acronym
BENEFIT
Official Title
BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
Collaborators
National Cancer Institute (NCI), Poudre Valley Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Control and Prevention
Keywords
Prevention & control, Diet, Functional food, Nutrition Assessment, Oryza sativa, Rice Bran, Phaseolus vulgaris L., Legumes, Microbiome, Metabolomics, Prebiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo-Control
Arm Type
Placebo Comparator
Arm Description
Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.
Arm Title
Cooked Navy Bean Powder
Arm Type
Experimental
Arm Description
Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.
Arm Title
Rice Bran
Arm Type
Experimental
Arm Description
Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo-Control Meals and Snacks
Other Intervention Name(s)
Whole food dietary intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Cooked Navy Bean Powder Meals and Snacks
Other Intervention Name(s)
Whole food dietary intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Rice Bran Meals and Snacks
Other Intervention Name(s)
Whole food dietary intervention
Primary Outcome Measure Information:
Title
Stool Microbiome Composition and Metabolome
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Navy Bean or Rice Bran metabolites in stool, urine and blood.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth P Ryan, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Facility Name
Poudre Valley Hospital Oncology Research
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25009453
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. doi: 10.2174/1573401310666140306005934.
Results Reference
result
PubMed Identifier
27689688
Citation
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.
Results Reference
result
PubMed Identifier
27461523
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(1):10.1002/mnfr.201500905. doi: 10.1002/mnfr.201500905. Epub 2016 Sep 12.
Results Reference
result
Links:
URL
http://csu-cvmbs.colostate.edu/academics/erhs/Pages/elizabeth-ryan-lab-human-studies.aspx
Description
Related Information
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Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
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