Overview

This trial is active, not recruiting.

Condition colorectal cancer control and prevention
Treatments placebo-control meals and snacks, cooked navy bean powder meals and snacks, rice bran meals and snacks
Sponsor Colorado State University
Collaborator National Cancer Institute (NCI)
Start date August 2010
End date December 2014
Trial size 45 participants
Trial identifier NCT01929122, 10-1038, 1R21CA161472-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Placebo Comparator)
Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.
placebo-control meals and snacks Whole food dietary intervention
(Experimental)
Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.
cooked navy bean powder meals and snacks Whole food dietary intervention
(Experimental)
Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.
rice bran meals and snacks Whole food dietary intervention

Primary Outcomes

Measure
Stool Microbiome Composition and Metabolome
time frame: 5 years

Secondary Outcomes

Measure
Navy Bean or Rice Bran metabolites in stool, urine and blood.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
Principal investigator Elizabeth P Ryan, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Colorado State University.