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Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01929122
Acronym
BENEFIT
Enrollment
29
Registered
2013-08-27
Start date
2010-08-31
Completion date
2014-12-31
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Control and Prevention

Keywords

Prevention & control, Diet, Functional food, Nutrition Assessment, Oryza sativa, Rice Bran, Phaseolus vulgaris L., Legumes, Microbiome, Metabolomics, Prebiotics

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.

Interventions

DIETARY_SUPPLEMENTPlacebo-Control Meals and Snacks
DIETARY_SUPPLEMENTCooked Navy Bean Powder Meals and Snacks
DIETARY_SUPPLEMENTRice Bran Meals and Snacks

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Poudre Valley Health System
CollaboratorOTHER
Colorado State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Stool Microbiome Composition and Metabolome5 years

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026