Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change from baseline in the fecal and serum metabolome with bean smoothie intervention
研究概览
简要总结
Beans are a forgotten staple food that shows promise in improving health. The goal of this study is to look at how bean supplementation affects metabolic and bowel health. In the long-term, the investigators believe this research will lead to a better understanding of the impact of beans on bowel health. The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future.
详细描述
Investigators are seeking adults planning for a standard of care colonoscopies (part of the participant's usual care). As part of this feeding study, a participant will be randomly assigned to either two weeks of a dry bean smoothie that the investigators will provide in addition to the participant's usual diet or continue with participant's usual diet without the bean smoothie (including the food and drink guidelines for the colonoscopy) 2 weeks before or after the participant colonoscopy.
Participants' involvement in this research will also include 2 research visits plus a visit on the day of their scheduled standard-of-care colonoscopy (each research visit will be 30-60 minutes in length, scheduled close to 2-4 weeks prior to the colonoscopy, day of the colonoscopy, as well as 2-12 weeks after the colonoscopy, depending on participant availability. The investigators expect about 25 people aged 35-75 to participate in this research.
Participation in this study will involve collecting breath tests, fecal (stool) samples, 8 Teaspoons of blood, clinical data, and participant questionnaire data. At the time of colonoscopy, the investigators will also sample the mucosa lining of the bowel and remnant (leftover or discarded) tissue from an intestine biopsy obtained as part of the participant's clinical care. Participants will be asked to sign a separate HIPAA authorization form to allow the investigators to collect information from participant's medical records. This information will become part of the research data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in the fecal and serum metabolome with bean smoothie intervention
时间窗: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Fecal and serum metabolomic assessment using an untargeted metabolomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
Compliance with the bean smoothie intervention
时间窗: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Mean percentage completion of bean smoothie intervention and mean percentage with positive breath test over 2 weeks
Effect of the bean smoothie intervention on serum biomarkers of health
时间窗: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Compare the percent with abnormal complete metabolic panel or complete blood count between paired baseline- and post- bean smoothie intervention vs. usual care
Impact of bean intervention on colonic tissue RNA markers of health
时间窗: 2-4 weeks prior to colonoscopy till colonoscopy
Compare colonic tissue RNA-seq assay between participants randomized to bean intervention vs usual care before the colonoscopy
Tolerance to the bean smoothie intervention
时间窗: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Compare the mean change in individual gastrointestinal symptoms and scores between paired baseline- and post- bean smoothie intervention vs. usual care. Patient-Reported Outcomes Measurement Information System (PROMIS) survey T sore range is 1-100, normal average T score is 50 (Standard deviation of 10).
Change in fecal abundance of microbiome genes with bean smoothie intervention
时间窗: 2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy
Fecal microbiome assessment using 16s/metagenomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
次要结局
- Change from baseline in body mass index (BMI)(2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy)
- Reported change from baseline in fitness level(2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy)
- Reported change from baseline in and exercise per week(2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy)
- Change from baseline in waist circumference(2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy)
- Change from baseline in body composition(2-4 weeks prior to colonoscopy, till 2-12 weeks after colonoscopy)