Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

Not Applicable

Completed

• Conditions: Colorectal Cancer Control and Prevention
• Interventions: Dietary Supplement: Placebo-Control Meals and Snacks; Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks; Dietary Supplement: Rice Bran Meals and Snacks

• Registration Number: NCT01929122
• Lead Sponsor: Colorado State University

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:

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-27
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-Control	Placebo-Control Meals and Snacks	Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.
Cooked Navy Bean Powder	Cooked Navy Bean Powder Meals and Snacks	Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.
Rice Bran	Rice Bran Meals and Snacks	Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.

Primary Outcome Measures

Name	Time	Method
Stool Microbiome Composition and Metabolome	5 years

Secondary Outcome Measures

Name	Time	Method
Navy Bean or Rice Bran metabolites in stool, urine and blood.	5 years

Trial Locations

Locations (2)

Poudre Valley Hospital Oncology Research; 🇺🇸 Fort Collins, Colorado, United States

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States