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

July 18, 2017 updated by: Elizabeth P Ryan, Colorado State University

BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523
        • Colorado State University
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Hospital Oncology Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Whole food dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stool Microbiome Composition and Metabolome
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Navy Bean or Rice Bran metabolites in stool, urine and blood.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Collaborators

National Cancer Institute (NCI)
Poudre Valley Health System

Investigators

  • Principal Investigator: Elizabeth P Ryan, PhD, Colorado State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1038
  • 1R21CA161472-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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