The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Changes in Blood Markers and Metabolites
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Regular Diet + Beans, Then Regular Diet - Beans
干预措施: Regular Diet (Other)
Regular Diet + Beans, Then Regular Diet - Beans
干预措施: Navy Beans (Canned) (Other)
Regular Diet - Beans, Then Regular Diet + Beans
干预措施: Regular Diet (Other)
Regular Diet - Beans, Then Regular Diet + Beans
干预措施: Navy Beans (Canned) (Other)
结局指标
主要结局
Changes in Blood Markers and Metabolites
时间窗: 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.
Changes in Stool 16S rRNA Gene Profiles
时间窗: 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.
次要结局
未报告次要终点