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Completed

NCT Number: NCT01929122

Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

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.

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Key information

Conditions

Colorectal Cancer Control and Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University, Fort Collins, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo-Control Meals and Snacks

Dietary Supplement

Other names: Whole food dietary intervention

Cooked Navy Bean Powder Meals and Snacks

Dietary Supplement

Other names: Whole food dietary intervention

Rice Bran Meals and Snacks

Dietary Supplement

Other names: Whole food dietary intervention

Primary outcomes

  1. Stool Microbiome Composition and Metabolome

    Time frame: 5 years

Secondary outcomes

  1. Navy Bean or Rice Bran metabolites in stool, urine and blood.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • National Cancer Institute (NCI)
  • Poudre Valley Health System

Registry information

Official study title

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

Acronym: BENEFIT

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2013
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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