Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

N/ACompletedNCT01929122

Colorado State University29 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Colorectal Cancer Control and Prevention

Interventions

Placebo-Control Meals and SnacksDIETARY_SUPPLEMENT

Cooked Navy Bean Powder Meals and SnacksDIETARY_SUPPLEMENT

Rice Bran Meals and SnacksDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Colorado State University

Fort Collins, Colorado, United States

Poudre Valley Hospital Oncology Research

Fort Collins, Colorado, United States

Outcomes

Primary Outcomes

Stool Microbiome Composition and Metabolome

Time frame: 5 years

Secondary Outcomes

Navy Bean or Rice Bran metabolites in stool, urine and blood.

Time frame: 5 years

Data from ClinicalTrials.gov

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