RDA Cereal Fiber Clinical
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Comparison of two test fibers (insoluble cereal bran and soluble arabinoxylan) and a control (maltodextrin) on gut beneficial bacteria
研究概览
简要总结
The importance of the gut microbiota for general health has been recently elucidated, but little is known about the impact of different types of nutrients on the gut microbiota. The soluble fiber in cereal by-products, arabinoxylan (AX), is known to be beneficial for generally promoting gut health. However, it is unclear whether consuming rice bran (RB), the source of AX, is equally helpful or better than consuming the extracted form of AX. This study aims to reveal the potential benefit of insoluble cereal bran fiber ingredients by comparing the effect of soluble arabinoxylan fiber alone and the mostly insoluble rice bran fiber, containing arabinoxylan, on intestinal health and gut microbiota. A placebo (maltodextrin) will be used as a control, with no significant changes expected in this group for the evaluated outcomes.
Participants will:
- Consume two different fiber supplements (soluble arabinoxylan or stabilized rice bran) as well as a placebo (maltodextrin) for 3 weeks each, separated by a 2-week washout period.
- Provide blood and stool samples at six different time points.
- Complete a food and gastrointestinal symptom diary during the intervention periods.
详细描述
Background:
This randomized, crossover clinical trial aims to evaluate the effects of two types of dietary fibers (soluble arabinoxylan and rice bran) compared to a control (maltodextrin) on gut microbiota and intestinal health in healthy adults aged 18-45. Insoluble rice bran, a fiber derived as a cereal by-product, may provide special support of a group of beneficial gut bacteria, and may compare well to its soluble arabinoxylan counterpart. This study will provide insights into whether rice bran, as a fiber source, offers additional benefits compared to the extracted soluble form alone.
Significance:
This study will contribute to the understanding of how different types of cereal fibers, specifically soluble arabinoxylan and rice bran, influence gut microbiota composition and overall intestinal health. The findings will have implications for dietary interventions aimed at promoting gut health, especially in relation to fiber intake from whole food sources compared to extracted fiber components.
Sample size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women.
- •Aged between 18-45 years.
- •Body mass index between 18.5 and 25 kg/m².
- •Able to read/speak English.
排除标准
- •Gastrointestinal disorders (inflammatory bowel disease, irritable bowel syndrome, gluten sensitivity/intolerance, etc.).
- •Those who took antibiotics 3 months before the study.
- •Individuals taking regular medication or supplements that might affect the gut microbiota.
- •Individuals undertaking weight-loss diets.
- •Unstable body weight (±3 kg in the past 3 months), and individuals below 110 lb.
- •Heavy drinkers (for men, consuming more than 4 drinks on any day or more than 14 drinks per week; for women, consuming more than 3 drinks on any day or more than 7 drinks per week).
- •Smokers (those who have smoked 100 cigarettes in their lifetime and who currently smoke cigarettes, even every day or occasionally).
- •Breastfeeding or pregnant women.
结局指标
主要结局
Comparison of two test fibers (insoluble cereal bran and soluble arabinoxylan) and a control (maltodextrin) on gut beneficial bacteria
时间窗: From enrollment to the end of treatment at 13 weeks.
The primary outcome of the study is change in butyrogenic Clostridium cluster XIVa gut bacteria.
次要结局
- Comparison of two tests (insoluble cereal bran and soluble arabinoxylan) and a control (maltodextrin) on fecal butyrate and intestinal barrier function(From enrollment to the end of treatment at 13 weeks.)
研究者
Bruce R. Hamaker
Professor
Purdue University