Trial | NCT01929122  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oryza sativa ...

  • Study Participants

    29
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.
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.
Study Started
Aug 31
2010
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Jul 21
2017

Dietary Supplement Placebo-Control Meals and Snacks

  • Other names: Whole food dietary intervention

Dietary Supplement Cooked Navy Bean Powder Meals and Snacks

  • Other names: Whole food dietary intervention

Dietary Supplement Rice Bran Meals and Snacks

  • Other names: Whole food dietary intervention

Placebo-Control Placebo Comparator

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

Cooked Navy Bean Powder Experimental

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

Rice Bran Experimental

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

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.
No Results Posted