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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02843425

Collaborator

(none)

Enrollment

Location

Arms

107.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

You are being asked to take part in this study because either you are a survivor who has a previous history of colorectal cancer or an MD Anderson patient who had a precancerous colorectal polyp or you have a previous history of colorectal cancer, and you have a current adult body mass index (BMI) score of 25 or higher.

The BMI score is used as an indicator of the level of body fat, based on height and weight.

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.

This is an investigational study.

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Prevention	Other: Regular Diet Other: Navy Beans (Canned)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

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

Actual Study Start Date :

Jul 25, 2016

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Canned Beans

Arm

Intervention/Treatment

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 Names:

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 Names:

Canned Beans

Outcome Measures

Primary Outcome Measures

Changes in Stool 16S rRNA Gene Profiles [Baseline to week 8]
The primary outcome measures will be intra- and inter-individual changes in stool 16S rRNA gene profiles at baseline, week 4 and week 8 for each cross-over period.
Changes in Blood Markers and Metabolites [Baseline to week 8]
The primary outcome measures will be intra- and inter-individual changes in blood makers and metabolites at baseline, week 8 for each cross-over period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult men and women 30+ years of age
Meet criteria for overweight or obesity via BMI or waist size
Underwent colonoscopy screening within the past 10 years
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
English-speaking and reside in the greater Houston/outlying areas and/or willing to travel for study-related visits at MD Anderson
Ability to complete web-based dietary assessments twice per week
Willingness to provide stool samples and undergo venipuncture
Willingness to consume/avoid beans as instructed during the 16 weeks from randomization

Exclusion Criteria:

Antibiotic use in the past month and unable/unwilling to be deferred to a later recruitment date
Current smoker
Heavy drinker (defined as more than 14 drinks per week)
Currently taking exclusionary prescription medications (including cytokines, immunosuppressive agents, chemopreventive drugs, bile acid sequestrants/selective cholesterol absorption inhibitors)
Regularly taking anti flatulence medications, probiotics and/or fiber supplements and unable/unwilling to discontinue for the purpose of the study
Major dietary restrictions relevant to the intervention
Hereditary colorectal cancer syndromes
Pregnant or lactating or planning to become pregnant