RDA Cereal Fiber Clinical
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Purdue University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Comparison of two test fibers (insoluble cereal bran and soluble arabinoxylan) and a control (maltodextrin) on gut beneficial bacteria
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men or women.
- •Aged between 18-45 years.
- •Body mass index between 18.5 and 25 kg/m².
- •Able to read/speak English.
Exclusion Criteria
- •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.
Arms & Interventions
Soluble Arabinoxylan
Participants in this arm will receive soluble arabinoxylan for 3 consecutive weeks.
Intervention: Soluble Arabinoxylan (Dietary Supplement)
Maltodextrin
Participants in this arm will consume maltodextrin for 3 consecutive weeks.
Intervention: Maltodextrin (Placebo) (Dietary Supplement)
Rice Bran
Participants in this arm will consume rice bran fiber for 3 consecutive weeks.
Intervention: Rice Bran (Dietary Supplement)
Outcomes
Primary Outcomes
Comparison of two test fibers (insoluble cereal bran and soluble arabinoxylan) and a control (maltodextrin) on gut beneficial bacteria
Time Frame: 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.
Secondary Outcomes
- 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.)
Investigators
Bruce R. Hamaker
Professor
Purdue University