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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two types of fiber supplements, soluble arabinoxylan and mostly insoluble rice bran, affect gut health and intestinal bacteria. The researchers aim to determine which fiber type better promotes a healthy gut. Participants will take each supplement for three weeks, with breaks in between, and provide blood and stool samples for analysis. This trial suits generally healthy adults who haven't experienced significant weight changes recently and aren't taking medications or supplements affecting gut health. As an unphased trial, it offers participants the chance to contribute to advancing knowledge about dietary fibers and gut health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both soluble arabinoxylan and rice bran are generally safe and well-tolerated. Studies have found that soluble arabinoxylan can improve gut health by altering gut bacteria and promoting regular stools, with no major side effects reported. It also serves as a beneficial fiber, supporting gut health without causing significant issues.

For rice bran, research indicates it can increase beneficial gut bacteria and improve gut health. It provides nutrients and prebiotics, which foster the growth of beneficial bacteria, enhancing gut immunity and reducing harmful bacteria. Rice bran has supported healthy gut function without serious side effects.

In summary, both treatments have been studied and found safe, with positive effects on gut health and no major reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because soluble arabinoxylan and rice bran offer natural, fiber-rich options for boosting gut health. Unlike many standard treatments that might rely on probiotics or medications, these treatments use the natural fibers found in grains to support digestive function. Soluble arabinoxylan has a unique ability to form a gel-like substance in the gut, which can help improve bowel regularity and gut bacteria balance. Meanwhile, rice bran is packed with various nutrients that can enhance gut health and overall well-being. This natural approach provides a promising alternative to traditional methods, focusing on dietary fibers that support the body's natural processes.

What evidence suggests that this trial's treatments could be effective for gut health?

This trial will compare the effects of soluble arabinoxylan and rice bran on gut health. Research has shown that soluble arabinoxylan, administered to participants in one arm of this trial, can improve gut health by altering gut bacteria and regulating stools. Studies indicate it boosts beneficial bacteria in the large intestine and helps reduce inflammation in gut-related issues. Early findings suggest it can change the makeup of gut bacteria and increase short-chain fatty acids (SCFAs), which benefit the gut.

Rice bran, consumed by participants in another arm of this trial, has enhanced gut health by repairing gut barrier problems and balancing gut bacteria. It provides nutrients and prebiotics, which promote the growth of good bacteria, boosting gut immunity and reducing harmful bacteria. Rice bran can also increase the presence of SCFA-producing bacteria, important for digestion. ^{3 5 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10458250/

Rice Bran Supplementation Ameliorates Gut Dysbiosis and ... Our finding revealed that rice bran supplementation ameliorated gut barrier dysfunction and gut dysbiosis and also maintained muscle mass by downregulating the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725001366

Effects of defatted rice bran-fortified bread on gut ... This is the first human study to show that a high-DF DRB-fortified bread improved DF intake, HDL cholesterol profiles, and may affect the gut microbiota ...

3. nature.com nature.com/articles/s41598-019-50344-4

Rice bran supplementation modulates growth, microbiota ... Rice bran supplementation provides nutrients, prebiotics and phytochemicals that enhance gut immunity, reduce enteric pathogens and diarrhea.

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1304045/full

Supplementation with soluble or insoluble rice-bran fibers ... Supplementation with soluble or insoluble rice-bran fibers increases short-chain fatty acid producing bacteria in the gut microbiota in vitro.

5. researchprotocols.org researchprotocols.org/2024/1/e59227/

Effects of Defatted Rice Bran–Fortified Bread on the Gut ... Secondary outcomes include clinical (cardiovascular risk profile), patient-reported (daily bread consumption and bowel movement, gut comfort, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0963996924013012

Comprehensive assessment of rice bran dietary fiber on ... Rice bran dietary fiber may modulate gut microbiome, specifically in enriching Bacteroides and inhibiting E_Shigella.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5209300/

Dietary Supplementation with Rice Bran or Navy Bean Alters ... Volunteers receiving rice bran or bean powder showed increased gut bacterial diversity and altered gut microbial composition at 28 days compared to baseline.

8. mdpi.com mdpi.com/2072-6643/15/16/3514

Rice Bran Supplementation Ameliorates Gut Dysbiosis and ... Our finding revealed that rice bran supplementation ameliorated gut barrier dysfunction and gut dysbiosis and also maintained muscle mass.