Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
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|
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|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Stool Microbiome Composition and Metabolome
time frame: 5 years
Navy Bean or Rice Bran metabolites in stool, urine and blood.
time frame: 5 years
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.
|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.|
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