Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

Study Overview
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Brief Summary
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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
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Objectives: 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. To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism. To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.

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

Conditions
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Colorectal Cancer Control and Prevention

Intervention / Treatment
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* Dietary Supplement: Placebo-Control Meals and Snacks
* Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks
* Dietary Supplement: Rice Bran Meals and Snacks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo-Control<br>Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days. | Dietary Supplement: Placebo-Control Meals and Snacks<br> <br> * Other names: Whole food dietary intervention;|
| Experimental: Cooked Navy Bean Powder<br>Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days. | Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks<br> <br> * Other names: Whole food dietary intervention;|
| Experimental: Rice Bran<br>Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days. | Dietary Supplement: Rice Bran Meals and Snacks<br> <br> * Other names: Whole food dietary intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Microbiome Composition and Metabolome |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navy Bean or Rice Bran metabolites in stool, urine and blood. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention & control, Diet, Functional food, Nutrition Assessment, Oryza sativa, Rice Bran, Phaseolus vulgaris L., Legumes, Microbiome, Metabolomics, Prebiotics