Prebiotic Fiber Supplementation for Gut Health

Overseen By Dalia Perelman, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Carbohydrate, Lipid metabolism drugs

Disqualifiers: Chronic inflammation, Major organ disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 years

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes people using medications that affect carbohydrate or lipid metabolism, so you may need to stop such medications to participate.

What data supports the effectiveness of the treatment Prebiotic Fiber Supplementation for Gut Health?

Research shows that prebiotic fiber can increase beneficial gut bacteria and improve gut function, which may help with conditions like constipation and support overall gut health. Additionally, prebiotics have been linked to improved metabolic health and quality of life in people with type 2 diabetes. ^{1 2 3 4 5}

Is prebiotic fiber supplementation safe for humans?

Prebiotic fiber supplementation is generally considered safe for humans, as studies have shown it is well tolerated at various doses and can promote beneficial gut bacteria without significant adverse effects. ^{2 6 7 8 9}

How is prebiotic fiber supplementation different from other treatments for gut health?

Prebiotic fiber supplementation is unique because it specifically promotes the growth of beneficial gut bacteria like Bifidobacterium by providing them with food, which can lead to improved gut health and the production of health-promoting metabolites. Unlike other treatments, it is a convenient, easy-to-use powder that can be mixed with water and taken daily, making it accessible for those with low fiber diets. ^{2 5 8 10 11}

What is the purpose of this trial?

The investigators propose a comprehensive, multiomic study that will integrate longitudinal data associating changes in specific gut bacteria and host in response to prebiotic fiber supplementation. These data will guide the development of an integrative biological signature relating bacterial-derived metabolites with biological outcome in the host. The open sharing of data generated by the proposed research represents a significant public resource that will support and accelerate future novel studies.

Research Team

Michael P Snyder, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for healthy individuals without major organ diseases, uncontrolled high blood pressure, diabetes (fasting blood sugar >126 mg/dL), extremely high triglycerides, a history of bariatric surgery, active psychiatric or eating disorders, heavy alcohol use, vascular disease or chronic inflammation. Pregnant or breastfeeding women are also excluded.

Inclusion Criteria

I am in good overall health.

Exclusion Criteria

Fasting Blood Sugar >126 mg/dL

You drink a lot of alcohol regularly.

Pregnancy/lactation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prebiotic fiber supplementation in various sequences to study microbiota and host changes

3-4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Prebiotic Fiber Supplementation

Trial Overview The study aims to understand how prebiotic fiber affects gut bacteria and the body's biological response by tracking changes in microbial metabolites. Participants will receive prebiotic fibers and researchers will collect data over time to develop a biological signature of these effects.

Participant Groups

Group I: ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan.

Group II: ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch.

Group III: ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin.

Group IV: ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan.

Group V: ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch.

Group VI: ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan.

Group VII: ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: rabinoxylan, Resistant Starch, Beta-Glucan, Inulin.

Group VIII: ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch.

Group IX: ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan.

Group X: ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch.

Group XI: ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch.

Group XII: ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan.

Group XIII: ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan.

Group XIV: ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin.

Group XV: ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan.

Group XVI: ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin.

Group XVII: ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan.

Group XVIII: ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin.

Group XIX: ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan.

Group XX: ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan.

Group XXI: ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan.

Group XXII: ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan.

Group XXIII: ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch.

Group XXIV: ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin Experimental Treatment 1 Intervention

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin.

Prebiotic Fiber Supplementation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prebiotic Fiber for:

• General health and wellness
• Gastrointestinal health

Approved in United States as Prebiotic Fiber for:

• General health and wellness
• Gastrointestinal health

Approved in Canada as Prebiotic Fibre Supplement for:

• General health and wellness
• Gastrointestinal health

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

In a 12-week study involving 192 participants with type 2 diabetes, a prebiotic fibre-enriched nutritional formula significantly improved health-related quality of life (measured by cT2-DDAS) and reduced glycated hemoglobin (HbA1c) levels compared to a placebo.

The study also found that the prebiotic formula increased the abundance of beneficial butyrate-producing bacteria in the gut, indicating a potential mechanism for its positive effects on metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microbiome-targeting fibre-enriched nutritional formula is well tolerated and improves quality of life and haemoglobin A1c in type 2 diabetes: A double-blind, randomized, placebo-controlled trial. Frias, JP., Lee, ML., Carter, MM., et al.[2023]

Dietary fiber has been recognized for its positive health effects since the 1970s, and certain types of fiber, known as prebiotics, can enhance the activity of beneficial gut bacteria.

Studying the metabolites produced from the fermentation of dietary fiber in the colon may provide clearer insights into how fiber contributes to health benefits, potentially helping to close the gap between recommended and actual fiber intake among consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics, Fermentable Dietary Fiber, and Health Claims. Delcour, JA., Aman, P., Courtin, CM., et al.[2018]

Prebiotics have been shown to potentially reduce the risk and severity of gastrointestinal infections and inflammation, including conditions like diarrhea and inflammatory bowel disease, based on a growing body of evidence.

They may also enhance mineral absorption and help in weight management by promoting feelings of fullness, but further research is needed to clarify how different prebiotics affect human health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals. Brownawell, AM., Caers, W., Gibson, GR., et al.[2023]

In a study involving 60 constipated females, the prebiotic mixture of inulin and partially hydrolyzed guar gum (I-PHGG) showed no significant improvement in bowel movement frequency compared to a placebo, indicating similar effectiveness in treating constipation.

However, I-PHGG was found to have beneficial effects on gut microbiota by significantly reducing the levels of harmful Clostridium bacteria, suggesting it may offer additional protective benefits beyond just alleviating constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbiota benefits after inulin and partially hydrolized guar gum supplementation: a randomized clinical trial in constipated women. Linetzky Waitzberg, D., Alves Pereira, CC., Logullo, L., et al.[2015]

A daily intake of 12 g of a prebiotic fiber supplement significantly increased beneficial Bifidobacterium species in the gut microbiome of 20 healthy adults on a low-fiber diet, indicating its efficacy in improving gut health.

The study also found that this prebiotic supplementation led to increased production of health-promoting metabolites, such as indolepropionate, suggesting potential benefits for overall health in individuals struggling to consume enough dietary fiber.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Omic Analyses Reveal Bifidogenic Effect and Metabolomic Shifts in Healthy Human Cohort Supplemented With a Prebiotic Dietary Fiber Blend. Kang, JW., Tang, X., Walton, CJ., et al.[2022]

In a study of 189 adults with fecal incontinence, fiber supplementation was generally well tolerated, with minimal gastrointestinal symptoms reported across all groups, indicating safety in using dietary fiber supplements.

The only significant symptom difference was a greater feeling of fullness in the psyllium group compared to placebo, and higher symptom severity was linked to emotional upset, which influenced participants' likelihood to withdraw or reduce their fiber dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms associated with dietary fiber supplementation over time in individuals with fecal incontinence. Bliss, DZ., Savik, K., Jung, HJ., et al.[2021]

Prebiotic fibers were found to positively alter the gut microbiota in both lean and genetically obese rats, promoting beneficial bacteria and potentially leading to a leaner phenotype by increasing Firmicutes and decreasing Bacteroidetes.

The changes in gut microbiota were linked to improvements in energy intake, glucose levels, insulin response, and reductions in liver cholesterol and triglycerides, suggesting that prebiotics could be a safe and effective strategy for managing obesity and insulin resistance, warranting further human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic fiber modulation of the gut microbiota improves risk factors for obesity and the metabolic syndrome. Parnell, JA., Reimer, RA.[2021]

Only resistant oligosaccharides, such as fructans and galactans, are well-established as prebiotics, meaning they can be metabolized by beneficial gut bacteria, while other types of dietary fibers are still being evaluated for their prebiotic potential.

This review helps classify dietary fibers into prebiotic categories, which can guide better food choices and promote the consumption of fiber-rich foods that may enhance gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fibers as beneficial microbiota modulators: A proposed classification by prebiotic categories. Rezende, ESV., Lima, GC., Naves, MMV.[2021]

A study involving 24 healthy adults showed that Promitor™ Soluble Corn Fibre (SCF) is well tolerated and can significantly increase the number of beneficial bifidobacteria in the gut microbiota, particularly at a dose of 6 g of fibre per day.

The increase in bifidobacteria observed with SCF is comparable to changes seen with established prebiotics like inulin-type fructans, suggesting that SCF may effectively promote gut health through its prebiotic properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic Potential of a Maize-Based Soluble Fibre and Impact of Dose on the Human Gut Microbiota. Costabile, A., Deaville, ER., Morales, AM., et al.[2023]

Prebiotic dietary fibers, such as fructooligosaccharides, inulin, and galactooligosaccharides, are beneficial for digestive health due to their ability to be fermented by gut microbiota, supporting various health benefits.

The paper identifies 8 categories of prebiotic fibers that promote digestive health through fermentation, highlighting the importance of these compounds in maintaining gut health, despite variations in their effects in human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Effects and Sources of Prebiotic Dietary Fiber. Carlson, JL., Erickson, JM., Lloyd, BB., et al.[2023]

Higher dietary fiber intake is associated with numerous health benefits, including reduced risk of cardiovascular disease, improved gut health, and lower body weights, with oligosaccharides now recognized as part of dietary fiber due to their physiological effects.

Oligosaccharides, such as inulin and fructo-oligosaccharides, are effective prebiotics that promote the growth of beneficial gut bacteria like Bifidobacterium, contributing to overall well-being and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiber and prebiotics: mechanisms and health benefits. Slavin, J.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A microbiome-targeting fibre-enriched nutritional formula is well tolerated and improves quality of life and haemoglobin A1c in type 2 diabetes: A double-blind, randomized, placebo-controlled trial. [2023]

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

Prebiotics, Fermentable Dietary Fiber, and Health Claims. [2018]

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

Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Microbiota benefits after inulin and partially hydrolized guar gum supplementation: a randomized clinical trial in constipated women. [2015]

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

Multi-Omic Analyses Reveal Bifidogenic Effect and Metabolomic Shifts in Healthy Human Cohort Supplemented With a Prebiotic Dietary Fiber Blend. [2022]

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

Symptoms associated with dietary fiber supplementation over time in individuals with fecal incontinence. [2021]

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

Prebiotic fiber modulation of the gut microbiota improves risk factors for obesity and the metabolic syndrome. [2021]

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

Dietary fibers as beneficial microbiota modulators: A proposed classification by prebiotic categories. [2021]

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

Prebiotic Potential of a Maize-Based Soluble Fibre and Impact of Dose on the Human Gut Microbiota. [2023]

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

Health Effects and Sources of Prebiotic Dietary Fiber. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Fiber and prebiotics: mechanisms and health benefits. [2022]