Colorectal Cancer PreventionNCT02843425
The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial
A study testing Regular Diet and Navy Beans (Canned) in people with Colorectal Cancer Prevention, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Colorectal Cancer Prevention
- What is being tested?
- Regular Diet and Navy Beans (Canned)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2016to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Colorectal Cancer Prevention
- Being tested
- Regular Diet, Navy Beans (Canned)
- Keywords
- Cancer Prevention, Precancerous colorectal polyps, Canned beans, Questionnaires, Surveys, Stool samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular DietOther
Participants follow their normal diet (not including beans for 8 weeks)
Navy Beans (Canned)Other
Also called Canned Beans
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.
| Study group | Role | What they receive |
|---|---|---|
| Regular Diet + Beans, Then Regular Diet - Beans | Experimental | Not described Receives: Other: Regular Diet; Other: Navy Beans (Canned) |
| Regular Diet - Beans, Then Regular Diet + Beans | Active comparator | Not described Receives: Other: Regular Diet; Other: Navy Beans (Canned) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Stool 16S rRNA Gene Profiles
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.
Measured: Baseline to week 8
Changes in Blood Markers and Metabolites
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.
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start25 Jul 2016
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer PreventionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carrie Daniel-MacDougall, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843425
- Sponsor's protocol ID
- 2016-0365
- Other IDs
- NCI-2016-01191
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2016
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang X, Irajizad E, Hoffman KL, Fahrmann JF, Li F, Seo YD, Browman GJ, Dennison JB, Vykoukal J, Luna PN, Siu W, Wu R, Murage E, Ajami NJ, McQuade JL, Wargo JA, Long JP, Do KA, Lampe JW, Basen-Engquist KM, Okhuysen PC, Kopetz S, Hanash SM, Petrosino JF, Scheet P, Daniel CR. Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial. EBioMedicine. 2023 Dec;98:104873. doi: 10.1016/j.ebiom.2023.104873. Epub 2023 Nov 30.
PubMed 38040541Zhang X, Browman G, Siu W, Basen-Engquist KM, Hanash SM, Hoffman KL, Okhuysen PC, Scheet P, Petrosino JF, Kopetz S, Daniel CR. The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. BMC Cancer. 2019 Dec 18;19(1):1233. doi: 10.1186/s12885-019-6400-z.
PubMed 31852462
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial
- ClinicalTrials.gov ID
- NCT02843425
- Acronym / sponsor ID
- 2016-0365
- Conditions
- Colorectal Cancer Prevention
- Keywords
- Cancer Prevention, Precancerous colorectal polyps, Canned beans, Questionnaires, Surveys, Stool samples
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Diet + Beans, Then Regular Diet - Beans | Experimental | Other: Regular Diet, Other: Navy Beans (Canned) |
| Regular Diet - Beans, Then Regular Diet + Beans | Active comparator | Other: Regular Diet, Other: Navy Beans (Canned) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular DietParticipants follow their normal diet (not including beans for 8 weeks) | Other | Regular Diet + Beans, Then Regular Diet - Beans, Regular Diet - Beans, Then Regular Diet + Beans |
| Navy Beans (Canned)Also: Canned BeansParticipants 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 | Regular Diet + Beans, Then Regular Diet - Beans, Regular Diet - Beans, Then Regular Diet + Beans |
Primary outcome
Changes in Stool 16S rRNA Gene Profiles
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 38040541Zhang X, Irajizad E, Hoffman KL, Fahrmann JF, Li F, Seo YD, Browman GJ, Dennison JB, Vykoukal J, Luna PN, Siu W, Wu R, Murage E, Ajami NJ, McQuade JL, Wargo JA, Long JP, Do KA, Lampe JW, Basen-Engquist KM, Okhuysen PC, Kopetz S, Hanash SM, Petrosino JF, Scheet P, Daniel CR. Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial. EBioMedicine. 2023 Dec;98:104873. doi: 10.1016/j.ebiom.2023.104873. Epub 2023 Nov 30.
- Results publication: PubMed 31852462Zhang X, Browman G, Siu W, Basen-Engquist KM, Hanash SM, Hoffman KL, Okhuysen PC, Scheet P, Petrosino JF, Kopetz S, Daniel CR. The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. BMC Cancer. 2019 Dec 18;19(1):1233. doi: 10.1186/s12885-019-6400-z.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Daniel-MacDougall, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Diet and Navy Beans (Canned) in people with Colorectal Cancer Prevention, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Stool 16S rRNA Gene Profiles (time frame: Baseline to week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02843425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.