124 Participants Needed

Butyrate + Polyphenol for Gut Health

SH
BM
Overseen ByBarbara Martinez

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment combining butyrate and polyphenol to assess its potential benefits for gut health. Researchers aim to determine if this combination can improve the balance of gut bacteria and reduce symptoms like stomach pain, gas, or bloating in individuals who frequently experience gastrointestinal discomfort. Participants should have experienced at least three symptoms, such as stomach pain, gas, bloating, diarrhea, or constipation, on a weekly basis. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for enhancing gut health.

Will I have to stop taking my current medications?

The trial requires you to stop taking any supplements containing butyrate, tributyrin, or polyphenols. You also need to refrain from taking any over-the-counter medications or supplements for gastrointestinal concerns unless you've been on a stable dose for more than 3 months before screening.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that butyrate and polyphenols are usually safe for people. Certain bacteria in the gut produce butyrate, which plays a crucial role in gut health. Studies suggest it can help protect against gut diseases, indicating its safety for individuals with gut issues.

Polyphenols, found in foods like fruits and vegetables, are also considered safe. They aid gut bacteria in producing butyrate, which benefits health. Studies have not reported any serious side effects from butyrate or polyphenols, suggesting they are safe for most people. However, individual reactions may vary, so participants should monitor their body's response if they join the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the Butyrate + Polyphenol formulation for gut health because it taps into natural compounds that may offer distinctive benefits over current treatments like probiotics and dietary fibers. Butyrate is a short-chain fatty acid known for its anti-inflammatory properties and ability to strengthen the gut barrier, while polyphenols are antioxidants that can reduce oxidative stress. Together, these ingredients might enhance gut health more effectively by targeting both inflammation and oxidative damage, offering a novel approach in comparison to the traditional methods.

What evidence suggests that this treatment might be an effective treatment for gastrointestinal discomfort?

Research has shown that butyrate can improve gut health by promoting intestinal growth, strengthening the immune system, and reducing inflammation. This trial will test a Butyrate + Polyphenol Formulation, which balances the gut microbiome—the group of bacteria in the stomach that affects digestion and health. Polyphenols work with gut bacteria to protect the gut lining, preventing harmful substances from entering the body. These compounds also help reduce inflammation and may protect against cancer. Studies have found that combining butyrate and polyphenols effectively reduces digestive symptoms and improves overall gut health. Participants in this trial will receive either the Butyrate + Polyphenol Formulation or a placebo to evaluate its effectiveness.16789

Who Is on the Research Team?

AS

Andrew Swick, PhD

Principal Investigator

Life Extension

Are You a Good Fit for This Trial?

This trial is for individuals with self-reported gastrointestinal discomfort, such as abdominal pain, constipation, or travelers' diarrhea. It's not specified who can't join the trial.

Inclusion Criteria

Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
Weight stable for the past six months (±6 lbs.)
Willing and able to give written informed consent
See 6 more

Exclusion Criteria

Pregnant, planning pregnancy, or breastfeeding
Currently participating in another clinical research study
History of a major change in dietary habits within the past 1 month
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the butyrate/polyphenol formulation or placebo for 14 days

2 weeks
1 visit (in-person) for laboratory assessment and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Butyrate + Polyphenol Formulation

Trial Overview

The study tests a butyrate-polyphenol formulation against a placebo to see if it improves gut health and eases gastrointestinal symptoms. Participants will answer questionnaires about their experiences.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Butyrate + Polyphenol FormulationActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Supplement Formulators, Inc.

Lead Sponsor

Trials
14
Recruited
570+

Citations

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