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The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial

This study is currently recruiting participants.
Verified June 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02843425
First Posted: July 25, 2016
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
The goal of this clinical research study is to learn if eating canned, pre-cooked beans can help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk.

Condition Intervention
Colorectal Cancer Prevention Other: Regular Diet Other: Navy Beans (Canned)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Changes in Stool 16S rRNA Gene Profiles [ Time Frame: Baseline to week 8, serial stool samples collected over each cross-over period ]
    Changes in stool 16S rRNA gene profiles will be at baseline, week 4, and week 8 for each cross-over period. Change scores of outcomes based on the differences between the beginning and the end of each study period; and by subtracting the change experienced over the control period from the change experienced over the intervention period.

  • Changes in gut microbiota profiles in serial stool samples collected over each cross-over period [ Time Frame: Baseline to week 8, serial stool samples collected over each cross-over period ]
    Changes in gut microbiome analyzed with stool metabolite profiles derived from serial stool samples at baseline, week 4, and week 8 for each cross-over period. Change scores of outcomes based on the differences between the beginning and the end of each study period; and by subtracting the change experienced over the control period from the change experienced over the intervention period.


Estimated Enrollment: 80
Actual Study Start Date: July 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regular Diet + Beans, Then Regular Diet - Beans Other: Regular Diet
Participants follow their normal diet (not including beans for 8 weeks)
Other: Navy Beans (Canned)
Participants add 1/2 cup of canned beans per day to their diets for the first 2 weeks. This is increased to 1 cup per day for the following 6 weeks of the study.
Other Name: Canned Beans
Active Comparator: Regular Diet - Beans, Then Regular Diet + Beans Other: Regular Diet
Participants follow their normal diet (not including beans for 8 weeks)
Other: Navy Beans (Canned)
Participants add 1/2 cup of canned beans per day to their diets for the first 2 weeks. This is increased to 1 cup per day for the following 6 weeks of the study.
Other Name: Canned Beans

Detailed Description:

Study Groups:

If you are found to be eligible, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (intervention or control). This is done because no one knows if one study group is better, the same, or worse than the other group. Both groups will be given a diet to follow for 8 weeks.

Intervention group participants will add canned beans into their diets beginning at ½ cup per day. This will be increased to 1 cup per day during the first 2 weeks, and then will continue at 1 cup per day for the following 6 weeks of the study. You will be asked to keep a log of your bean consumption during this time.

Control group participants will be instructed to follow their normal diet (not including beans) for 8 weeks.

Length of Study:

Your active participation on the study will last a total of 20 weeks. Your participation on the study will be over after the follow-up period.

Long-Term Follow-Up:

Up to 2 times each year for up to 5 years, a member of the study staff will contact you and ask about how you are doing. You will be contacted by phone, email, or standard mail. These calls will last 15-20 minutes each.

At 6 months and 1 year after your last visit, you will complete the same questionnaires you completed at screening.

Study Visits:

At each visit, your waist measurements and weight will be collected.

Every 4 weeks (Visits 2, 3, 4, 5, and 6), blood (about 3 tablespoons) will be drawn for routine tests. You will be asked to bring a stool sample to each visit and mail a stool sample at the end of week 1 during the intervention. You will be provided with a container and instructions to collect each stool sample. You may send your stool sample back to the study staff by mail. If you choose to send it by mail, you will be given a pre-paid envelope for this.

At Visit 4, your study group assignment will be switched, and you will be assigned to the opposite group and diet from your first assignment (meaning intervention group members will be switched to the control group as well as the other way around). You will follow this new diet for the remaining 8 weeks.

This is an investigational study.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Current or former MD Anderson patient (MRN)
  2. Adult men and women 30+ years of age
  3. Meet criteria for overweight or obesity via BMI or waist size
  4. Underwent colonoscopy screening within the past 10 years
  5. History of pathology-confirmed precancerous polyp of the colon or rectum; OR Colorectal cancer survivor who has completed treatment with adequate maintenance of bowel length (eligible: hemicolectomy or low anterior resection; ineligible: total or near total colectomy, greater than 10 cm of small bowel resection) and normalized bowel habits
  6. English-speaking and reside in the greater Houston/outlying areas and/or willing to travel for study-related visits at MD Anderson
  7. Ability to complete web-based dietary assessments twice per week
  8. Willingness to provide stool samples and undergo venipuncture
  9. Willingness to consume/avoid beans as instructed during the 16 weeks from randomization

Exclusion Criteria:

  1. Antibiotic use in the past month. Can be deferred to a later recruitment date once off antibiotics for 1 month prior to study commencement
  2. Current smoker
  3. Heavy drinker (defined as more than 14 drinks per week)
  4. Currently taking exclusionary prescription medications (including cytokines, immunosuppressive agents, chemopreventive drugs, bile acid sequestrants/selective cholesterol absorption inhibitors)
  5. Regularly taking anti flatulence medications, probiotics and/or fiber supplements unless willing to discontinue temporarily (if not prescribed by physician) prior to entering study
  6. Major dietary restrictions relevant to the intervention
  7. Hereditary colorectal cancer syndromes
  8. Pregnant or lactating or planning to become pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843425


Contacts
Contact: Carrie Daniel-MacDougall, PHD 713-563-5783 BEGONE@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Carrie Daniel-MacDougall, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02843425     History of Changes
Other Study ID Numbers: 2016-0365
NCI-2016-01191 ( Other Identifier: NCI CTRP )
First Submitted: July 18, 2016
First Posted: July 25, 2016
Last Update Posted: June 28, 2017
Last Verified: June 2017

Keywords provided by M.D. Anderson Cancer Center:
Cancer Prevention
Precancerous colorectal polyps
Canned beans
Questionnaires
Surveys
Stool samples

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases