This study is being conducted to demonstrate short chain fatty acid (SCFA), specifically butyrate, generation in stool, blood and urine in response to oral intake of ButyraGen™.
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening. This is a single-center study will follow a randomized, single-blinded parallel design with two doses. It features a 1-week intake of control followed by 3 weeks of either low dose (200 mg ButyraGen, containing 100 mg tributyrin) or high dose (400 mg, containing 200 mg tributyrin) of intervention to evaluate the effects of the active ingredient tributyrin after chronic intake in generally healthy individuals. A planned sample size of 24 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 6 study day visits. The study will last about 5 weeks to complete all study procedures for each participant. The initial screening visit will provide subjects with their site-specific, IRB approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), fasting blood sample screened for complete blood count (CBC) and basic metabolic panel (BMP), and surveys related to general eating, health, mood and exercise habits. Subjects will be randomized to 1 of 2 interventions: low dose (100 mg - tributyrin) or high does (200 mg - tributyrin). All subjects will receive 1 week of control (0 mg - tributyrin), then same treatment (low or high dose) for the remaining duration of the study. Treatment codes will be maintained by the principal investigator. Two of the 6 study days (first and last) will last \~7 hours and include a lactulose-mannitol test. In general, this test will ask you to collect your 1st urine of the day, drink a sugary beverage and collect all urine for the next 6 hours after the drink. The other 4 study days will last \~2 hours. Subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected via a butterfly needle by a certified phlebotomist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
29
ButyraGen™ contains tributyrin as the primary active as well as Sunfiber®, a partially hydrolyzed guar fiber, and acacia fiber.
Clinical Nutrition Research Center
Chicago, Illinois, United States
SCFAs in stool, blood and urine samples
Outcome measure will be quantified via GC-FID
Time frame: Baseline to 4 weeks
Lactulose-mannitol test for leaky gut
Outcome measure will be analyzed by Genova Diagnostics
Time frame: Baseline to 4 weeks
Questionnaire for study product tolerability
Yes or no question for experiences felt during study. If yes, rated based on how often - "much less than usual" to "much more than usual".
Time frame: Baseline to 4 weeks
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