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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
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 22, 2013
Last Updated
July 18, 2017
Sponsor
Colorado State University
Collaborators
National Cancer Institute (NCI), Poudre Valley Health System
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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
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Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

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