BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Stool Microbiome Composition and Metabolome
研究概览
简要总结
The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.
详细描述
Objectives:
- To learn about how increased cooked navy bean powders or rice bran dietary intake affect the stool microbiota of colorectal cancer survivors and healthy adults.
- To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
- To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age.
- •Be a Colorectal Cancer Survivor that is a minimum of 4 months post chemotherapy/radiation treatment. OR be a healthy adult with no prior history of treatment for cancer.
- •BMI between 25-35
- •no previous or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease free for five years.
- •Ability to complete questionnaire(s) and dietary food logs
- •Willingness to consume meals/snacks provided for 28 consecutive days
- •Drink less than or equal to one alcoholic drink/day
排除标准
- •History of food allergies and/or major dietary restrictions
- •Pregnant or lactating or planning to become pregnant
- •Self identified as a smoker
- •Taking prescribed medication to control their lipids
- •Taking Bean-O, other anti-flatulence medications or prolonged antibiotic use (one month)
- •Have a history of gallstones.
研究组 & 干预措施
Placebo-Control
Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.
干预措施: Placebo-Control Meals and Snacks (Dietary Supplement)
Cooked Navy Bean Powder
Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.
干预措施: Cooked Navy Bean Powder Meals and Snacks (Dietary Supplement)
Rice Bran
Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.
干预措施: Rice Bran Meals and Snacks (Dietary Supplement)
结局指标
主要结局
Stool Microbiome Composition and Metabolome
时间窗: 5 years
次要结局
- Navy Bean or Rice Bran metabolites in stool, urine and blood.(5 years)
研究者
Elizabeth P Ryan
Assistant Professor of Toxicology and Nutrition
Colorado State University