Soluble Arabinoxylan + Rice Bran for Gut Health in Healthy Adults

Overseen By Mirian A de Campos Costa, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Must not be taking: Antibiotics, Gut microbiota supplements

Disqualifiers: Gastrointestinal disorders, Weight-loss diets, others

Compensation: Varies

Number of Visits: 7

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial excludes individuals taking regular medication or supplements that might affect the gut microbiota, so you may need to stop taking such medications to participate.

Is Soluble Arabinoxylan + Rice Bran safe for human consumption?

Research on arabinoxylan, a type of dietary fiber found in rice and wheat, suggests it is generally safe for human consumption. Studies have shown it can positively affect gut health by altering gut bacteria and improving stool consistency without major side effects. ^{1 2 3 4 5}

How does the treatment with Soluble Arabinoxylan and Rice Bran differ from other gut health treatments?

This treatment is unique because it uses soluble arabinoxylan from rice bran, which acts as a prebiotic (a substance that promotes the growth of beneficial gut bacteria) to improve gut health by increasing beneficial bacteria and short-chain fatty acids in the gut. Unlike other treatments, it specifically targets the gut microbiota composition and is derived from natural cereal grains, making it a novel approach for enhancing gut health in healthy adults. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Maltodextrin, Rice Bran, Soluble Arabinoxylan for gut health in healthy adults?

Research shows that soluble arabinoxylan from rice bran can positively change gut bacteria and increase beneficial compounds in the gut, which may improve gut health. Additionally, wheat bran-derived arabinoxylan has been shown to soften stool consistency and increase beneficial gut bacteria in healthy adults. ^{1 2 5 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in contributing to research on gut health. Participants will consume fiber supplements and a placebo, provide blood and stool samples, and keep a food/symptom diary. Specific eligibility details are not provided.

Inclusion Criteria

Body mass index between 18.5 and 25 kg/m²

I am either male or female.

Exclusion Criteria

Currently on weight-loss diets

Smokers (100 cigarettes lifetime and current smoker)

Breastfeeding or pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants consume soluble arabinoxylan, rice bran, or maltodextrin for 3 weeks each, separated by a 2-week washout period

13 weeks

Weekly visits to receive supplements

Sample Collection

Biological samples (stool and blood) are collected on the first and last day of each intervention phase

Throughout intervention

6 visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maltodextrin
• Rice Bran
• Soluble Arabinoxylan

Trial Overview The study tests the effects of soluble arabinoxylan fiber versus rice bran fiber on gut microbiota in comparison to a placebo (maltodextrin). It involves consuming each supplement for three weeks with breaks in between and monitoring changes.

How Is the Trial Designed?

Group I: Soluble Arabinoxylan Experimental Treatment 1 Intervention

Participants in this arm will receive soluble arabinoxylan for 3 consecutive weeks.

Group II: Rice Bran Experimental Treatment 1 Intervention

Participants in this arm will consume rice bran fiber for 3 consecutive weeks.

Group III: Maltodextrin Placebo Group 1 Intervention

Participants in this arm will consume maltodextrin for 3 consecutive weeks.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Rural Development Administration (RDA) of the Republic of Korea

Collaborator

Trials

1

Recruited

30+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

In Vitro Fecal Fermentation Patterns of Arabinoxylan from Rice Bran on Fecal Microbiota from Normal-Weight and Overweight/Obese Subjects. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Arabinoxylan fibre improves metabolic control in people with Type II diabetes. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Repeated Consumption of Partially Hydrolyzed Guar Gum on Fecal Characteristics and Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled, and Parallel-Group Clinical Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Elucidating the role of the gut microbiota in the physiological effects of dietary fiber. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Wheat-Derived Arabinoxylan on the Gut Microbiota Composition and Colonic Regulatory T Cells. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in the Human Gut Microbiome during Dietary Supplementation with Modified Rice Bran Arabinoxylan Compound. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Evidence of intermolecular associations of β-glucan and high-molar mass xylan in a hot water extract of raw oat groat. [2022]