ButyraGen™, Short Chain Fatty Acids and Gut Microbiome

NCT05601635 | Completed

• 1 other identifier: IRB-2023-25
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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™.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• SCFAs in stool, blood and urine samples

  Outcome measure will be quantified via GC-FID

  Baseline to 4 weeks

Secondary Outcomes (2)

• Lactulose-mannitol test for leaky gut

  Baseline to 4 weeks

• Questionnaire for study product tolerability

  Baseline to 4 weeks

Study Arms (2)

High dose

ACTIVE COMPARATOR

Dietary supplement containing 200 mg of active ingredient tributyrin

Dietary Supplement: ButyraGen™

Low dose

ACTIVE COMPARATOR

Dietary supplement containing 100 mg of active ingredient tributyrin

Dietary Supplement: ButyraGen™

Interventions

ButyraGen™ DIETARY_SUPPLEMENT

ButyraGen™ contains tributyrin as the primary active as well as Sunfiber®, a partially hydrolyzed guar fiber, and acacia fiber.

High dose; Low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male or female, 18 years of age, inclusive.
• Subject has a BMI of 20.0-30.0 kg/m2, inclusive and a weight ≥ 110 lb. at the screening visit.
• Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
• Subject is willing to follow study instructions, including compliance with certain dietary restrictions, consumption of study products, and study visit schedule.
• Subject is judged to be in good health on the basis of the medical history.
• Subject is willing to abstain from alcohol consumption for 24 hours prior to the study visit.
• Subject is willing to maintain a stable dose of current medications not interfering with study outcomes, including birth control, throughout the study duration.
• Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator/s and is willing to complete study procedures.

You may not qualify if:

• Subject has fasting finger prick glucose \>125 mg/dL.
• Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
• Subject has had major trauma or a surgical event within 2 months of study visit 1.
• Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (ie. liposuction, laser fat removal, etc)
• Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
• Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Subject has a history of extreme dietary habits, as judged by the Investigator (e.g., Atkins diet, etc.).
• Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• Subject has a known intolerance or sensitivity to any ingredients in the study products.
• Subject has used medications known to influence carbohydrate and lipid metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids 2 weeks prior to visit 0 and throughout the study or other medication(s) that may interfere with results of study.
• Subject taking fiber supplements.
• Subject taking systemic steroids, extreme alcohol use, or drug user.
• Subject has a vein access score of less than 7
• Subject is a female who is pregnant, planning to be pregnant during the study period or lactating.
• Subject is a current smoker. Past smoker abstinence for less than 1 years.

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 1, 2022
• Study Start: October 19, 2022
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)