Clinical trial NCT01929122: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
Official title: BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Poudre Valley Health System
First posted: 2013-08-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stool Microbiome Composition and Metabolome
timeFrame: 5 years
Secondary outcomes:
measure: Navy Bean or Rice Bran metabolites in stool, urine and blood.
timeFrame: 5 years
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital Oncology Research
state: Colorado
Study officials:
affiliation: Colorado State University
name: Elizabeth P Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borresen EC, Gundlach KA, Wdowik M, Rao S, Brown RJ, Ryan EP. Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. Curr Nutr Food Sci. 2014 May;10(2):112-119. doi: 10.2174/1573401310666140306005934.
citation: Borresen EC, Brown DG, Harbison G, Taylor L, Fairbanks A, O'Malia J, Bazan M, Rao S, Bailey SM, Wdowik M, Weir TL, Brown RJ, Ryan EP. A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. Nutr Cancer. 2016 Nov-Dec;68(8):1269-1280. doi: 10.1080/01635581.2016.1224370. Epub 2016 Sep 30.
citation: Sheflin AM, Borresen EC, Kirkwood JS, Boot CM, Whitney AK, Lu S, Brown RJ, Broeckling CD, Ryan EP, Weir TL. Dietary supplementation with rice bran or navy bean alters gut bacterial metabolism in colorectal cancer survivors. Mol Nutr Food Res. 2017 Jan;61(1):10.1002/mnfr.201500905. doi: 10.1002/mnfr.201500905. Epub 2016 Sep 12.