NCT01929122

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

4.3 years

First QC Date

August 22, 2013

Last Update Submit

July 18, 2017

Conditions

Colorectal Cancer Control and Prevention

Keywords

Prevention & controlDietFunctional foodNutrition AssessmentOryza sativaRice BranPhaseolus vulgaris L.LegumesMicrobiomeMetabolomicsPrebiotics

Outcome Measures

Primary Outcomes (1)

  • Stool Microbiome Composition and Metabolome

    5 years

Secondary Outcomes (1)

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

    5 years

Study Arms (3)

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.

Dietary Supplement: Placebo-Control Meals and Snacks

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.

Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks

Rice Bran

EXPERIMENTAL

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

Interventions

Placebo-Control Meals and SnacksDIETARY_SUPPLEMENT
Also known as: Whole food dietary intervention
Placebo-Control
Cooked Navy Bean Powder Meals and SnacksDIETARY_SUPPLEMENT
Also known as: Whole food dietary intervention
Cooked Navy Bean Powder
Rice Bran Meals and SnacksDIETARY_SUPPLEMENT
Also known as: Whole food dietary intervention
Rice Bran

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Poudre Valley Hospital Oncology Research

Fort Collins, Colorado, 80528, United States

Location

Related Publications (3)

  • Borresen EC, Gundlach KA, Wdowik M, Rao S, Brown RJ, Ryan EP. Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. Curr Nutr Food Sci. 2014 May;10(2):112-119. doi: 10.2174/1573401310666140306005934.

    PMID: 25009453RESULT

  • Borresen EC, Brown DG, Harbison G, Taylor L, Fairbanks A, O'Malia J, Bazan M, Rao S, Bailey SM, Wdowik M, Weir TL, Brown RJ, Ryan EP. A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. Nutr Cancer. 2016 Nov-Dec;68(8):1269-1280. doi: 10.1080/01635581.2016.1224370. Epub 2016 Sep 30.

    PMID: 27689688RESULT

  • Sheflin AM, Borresen EC, Kirkwood JS, Boot CM, Whitney AK, Lu S, Brown RJ, Broeckling CD, Ryan EP, Weir TL. Dietary supplementation with rice bran or navy bean alters gut bacterial metabolism in colorectal cancer survivors. Mol Nutr Food Res. 2017 Jan;61(1):10.1002/mnfr.201500905. doi: 10.1002/mnfr.201500905. Epub 2016 Sep 12.

    PMID: 27461523RESULT

Related Links

MeSH Terms

Interventions

Snacks

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Elizabeth P Ryan, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Toxicology and Nutrition

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 27, 2013

Study Start

August 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(2)