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

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Status: Closed to Accrual

Description

This randomized pilot trial studies how well beans work in improving the gut microbiome and blood biomarkers in overweight and obese colorectal adenoma patients and cancer survivors. Eating canned, pre-cooked beans may help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk in patients with or without a previous history of colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • Meet criteria for overweight or obesity via body mass index (BMI) or waist size
  • Underwent colonoscopy screening in 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

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To examine the effect of increased consumption of dry beans on the gut microbiome and blood biomarkers of overweight and obese individuals otherwise consuming their usual diet.

Ia. To examine the effect of increased consumption of dry beans on the diversity and composition of the gut microbiome.

Ib. To examine the relationship between changes in the gut microbiome and changes in host biomarkers, including established fecal surrogates of gut inflammation and integrity, circulating adipocytokines, and a comprehensive blood lipid and metabolic panel.

SECONDARY OBJECTIVES:

I. To pilot the field and research procedures of a prospective randomized crossover dietary intervention of dry beans, including compliance in our target population and the modifying effects of the baseline gut microbiome and usual diet on individual’s response to the intervention.

OUTLINE: Participants are randomized to 1 of 2 groups.

Group I (Intervention Diet): Participants add 1/2 cup of canned beans per day to their diet for 2 weeks, and then 1 cup per day for 6 weeks. After completion of intervention diet, participants crossover into control diet for 8 weeks.

Group II (Control Diet): Participants will follow their normal diet (not including beans) for 8 weeks and then crossover to intervention diet for 8 weeks.

After the completion of study treatment, patients are followed up at 6 months and 1 year and twice a year for up to 5 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Carrie Daniel-MacDougall

Trial IDs

Primary ID 2016-0365
Secondary IDs NCI-2016-01191
Clinicaltrials.gov ID NCT02843425