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Prebiotic Fiber Supplement

Prebiotic Fiber Supplementation for Gut Health

N/A

Recruiting

Led By Michael P Snyder, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial will study how changes in gut bacteria relate to prebiotic fiber supplementation in order to develop a biological signature for the effect of these supplements on the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects from prebiotic fiber supplementation may include bloating, gas, discomfort in the digestive tract or allergic reactions. Specific side effects would be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biological signatures identified from the integration of microbiome-host omes

Comprehensive phenotyping of host profile during prebiotic intervention

Prebiotics

Trial Design

24Treatment groups

Experimental Treatment

Group I: ARM 9: Beta-Glucan, Resistant Starch, Inulin, ArabinoxylanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Resistant Starch, 3- Inulin, 4- Arabinoxylan

Group II: ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant StarchExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Arabinoxylan, 3- Inulin, 4- Resistant Starch

Group III: ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, InulinExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Arabinoxylan, 3- Resistant Starch, 4- Inulin

Group IV: ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-GlucanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan, 2- Inulin, 3- Resistant Starch, 4- Beta-Glucan

Group V: ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant StarchExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Inulin 3- Beta-Glucan 4- Resistant Starch

Group VI: ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-GlucanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Resistant Starch 3- Inulin 4- Beta-Glucan

Group VII: ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, InulinExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Resistant Starch 3- Beta-Glucan 4- Inulin

Group VIII: ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant StarchExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Beta-Glucan 3- Inulin 4- Resistant Starch

Group IX: ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-GlucanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Arabinoxylan, 3- Resistant Starch, 4- Beta-Glucan

Group X: ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant StarchExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Arabinoxylan, 3- Beta-Glucan, 4- Resistant Starch

Group XI: ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant StarchExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Beta-Glucan, 3- Arabinoxylan, 4- Resistant Starch

Group XII: ARM 21: Inulin, Beta-Glucan, Resistant Starch, ArabinoxylanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Beta-Glucan, 3- Resistant Starch, 4- Arabinoxylan

Group XIII: ARM 20: Inulin, Resistant Starch, Beta-Glucan, ArabinoxylanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Resistant Starch, 3- Beta-Glucan, 4- Arabinoxylan

Group XIV: ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, InulinExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Beta-Glucan 3- Resistant Starch 4- Inulin

Group XV: ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-GlucanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Resistant Starch, 3- Arabinoxylan, 4- Beta-Glucan

Group XVI: ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, InulinExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Beta-Glucan, 3- Arabinoxylan, 4- Inulin

Group XVII: ARM 17: Resistant Starch, Beta-Glucan, Inulin, ArabinoxylanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Beta-Glucan, 3- Inulin, 4- Arabinoxylan

Group XVIII: ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, InulinExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Arabinoxylan, 3- Beta-Glucan, 4- Inulin

Group XIX: ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-GlucanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Arabinoxylan, 3- Inulin, 4- Beta-Glucan

Group XX: ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-GlucanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Inulin, 3- Arabinoxylan, 4- Beta-Glucan

Group XXI: ARM 13: Resistant Starch, Inulin, Beta-Glucan, ArabinoxylanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch 2- Inulin 3- Beta-Glucan 4- Arabinoxylan

Group XXII: ARM 12: Beta-Glucan, Inulin, Resistant Starch, ArabinoxylanExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Inulin, 3- Resistant Starch, 4- Arabinoxylan

Group XXIII: ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant StarchExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Inulin, 3- Arabinoxylan, 4- Resistant Starch

Group XXIV: ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, InulinExperimental Treatment1 Intervention

Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Resistant Starch, 3- Arabinoxylan, 4- Inulin

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,873 Total Patients Enrolled

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,495 Total Patients Enrolled

1 Trials studying Prebiotics

18 Patients Enrolled for Prebiotics

Michael P Snyder, PhDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

818 Total Patients Enrolled

Media Library

Prebiotic Fiber Supplementation (Prebiotic Fiber Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03925597 — N/A

Prebiotics Research Study Groups: ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin, ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch, ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin, ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan, ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch, ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan, ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan, ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch, ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan, ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch, ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan, ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch, ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin, ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin, ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin, ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch, ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan, ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin, ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan, ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan, ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan, ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan, ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan, ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan

Prebiotics Clinical Trial 2023: Prebiotic Fiber Supplementation Highlights & Side Effects. Trial Name: NCT03925597 — N/A

Prebiotic Fiber Supplementation (Prebiotic Fiber Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03925597 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must participants fulfill to join the experiment?

"This clinical investigation is seeking 20 volunteers, aged between 35 and 65 years old, with prebiotics. Additionally, it is essential that these participants also showcase a good state of health."

Answered by AI

Are individuals younger than 60 years of age eligible to participate in this experiment?

"This research is accepting patients aged 35 years or older, but under 65."

Answered by AI

Are there any patient slots available in this research program?

"As indicated on clinicaltrials.gov, this trial is open to participants and actively accepting candidates. This particular medical study was posted in January of 2020 and its most recent alteration occurred May 21st 2021."

Answered by AI

How many individuals are anticipated to be part of this medical experiment?

"Affirmative. Details on clinicaltrials.gov point to this medical trial, which was first shared on January 21st 2020, actively recruiting participants. The investigators need 20 individuals from one facility to take part in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

Michael Snyder 2020. "Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03925597.