Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

Description

The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms

Conditions

Gut Health

Study Overview

Study Details

Study overview

The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

Condition
Gut Health
Intervention / Treatment

-

Contacts and Locations

Fort Lauderdale

Life Extension Clinical Research, Inc., Fort Lauderdale, Florida, United States, 33304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Ambulatory, male or female, 21-70 years of age
  • 2. A BMI of 18.5 -34.9
  • 3. . Experiences at least three conditions involving gastrointestinal health on a weekly basis
  • 4. Are comfortable fasting overnight
  • 5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days
  • 6. Considered to be generally healthy on the basis of medical history
  • 7. Willing to follow study instructions, including compliance with the study procedures and requirements
  • 1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
  • 2. Currently on a galactose/lactose restricted diet
  • 3. Having taken proton pump inhibitors within the past 3 months
  • 4. History of oral antibiotic use within the past 3 months
  • 5. Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters
  • 6. A medical or surgical event requiring hospitalization, outpatient visits or emergency room visits within the past 5 years or in the judgment of the Study Investigator /Sub-I would preclude participation in the study
  • 7. Current or previous history of diabetes
  • 8. History of a major change in dietary habits with the past 1 month
  • 9. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose
  • 10. Women who are lactating, pregnant or planning pregnancy within the next two months
  • 11. Having donated blood or received a blood transfusion within 30 days before screening
  • 12. Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Supplement Formulators, Inc.,

Andrew Swick, Ph.D, PRINCIPAL_INVESTIGATOR, Life Extension

Study Record Dates

2025-02-21