Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial (BENEFIT)

Colorado State University (CSU)

Status: Completed

Conditions: Colorectal Cancer Control and Prevention

Treatments: Dietary Supplement: Rice Bran Meals and Snacks; Dietary Supplement: Placebo-Control Meals and Snacks; Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01929122

1R21CA161472-01A1 (U.S. NIH Grant/Contract)

10-1038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 3 patient groups, including a placebo group

Placebo-Control

Placebo Comparator group

Description:

Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.

Treatment:

Dietary Supplement: Placebo-Control Meals and Snacks

Cooked Navy Bean Powder

Experimental group

Description:

Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.

Treatment:

Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks

Rice Bran

Experimental group

Description:

Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.

Treatment:

Dietary Supplement: Rice Bran Meals and Snacks