Phase
Condition
N/ATreatment
Butyrate + Polyphenol Formulation
Placebo
Butyrate Formulation
Clinical Study ID
Ages 21-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ambulatory, male or female, 21-70 years of age
A BMI of 18.5 -34.9
. Experiences at least three conditions involving gastrointestinal health on aweekly basis
Are comfortable fasting overnight
Are able to complete study procedures for up to approximately 6 hours on 2 separatedays
Considered to be generally healthy on the basis of medical history
Willing to follow study instructions, including compliance with the study proceduresand requirements
Exclusion
Exclusion Criteria:
Unable to provide a urine specimen, stool specimen or blood sample from a fingerstick
Currently on a galactose/lactose restricted diet
Having taken proton pump inhibitors within the past 3 months
History of oral antibiotic use within the past 3 months
Current or previous history of gastrointestinal disease, cancer, infection orsurgery that may interfere with the outcome parameters
A medical or surgical event requiring hospitalization, outpatient visits oremergency room visits within the past 5 years or in the judgment of the StudyInvestigator /Sub-I would preclude participation in the study
Current or previous history of diabetes
History of a major change in dietary habits with the past 1 month
Known intolerance or allergy to sugar alcohols including mannitol, sorbitol,xylitol, lactulose or lactose
Women who are lactating, pregnant or planning pregnancy within the next two months
Having donated blood or received a blood transfusion within 30 days before screening
Currently participating in another clinical research study or participated inanother clinical research study within 30 days prior to screening
Study Design
Study Description
Connect with a study center
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida 33304
United StatesActive - Recruiting
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