A Pharmacokinetic Comparison of Three Butyrate Products

This study is a randomized, three-arm, interventional study of N=10 apparently healthy men. This study will quantify plasma butyrate responses to a single dose of three different butyrate products.

Study Overview

• Status: Completed
• Conditions: Gastro-Intestinal Disorder
• Intervention / Treatment: Dietary supplement: Lysine butyrate; Dietary supplement: Sodium Butyrate; Dietary supplement: Tributyrin

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • The Center for Applied Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provide voluntary signed and dated informed consent.
• Be in good health as determined by medical history and routine blood chemistries.
• Age between the ages of 25 and 45 (inclusive).
• Body Mass Index of 18.5-24.9 (inclusive).
• Body weight of at least 110 pounds.
• Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
• Normal seated, resting heart rate (<90 per minute).
• Willing to duplicate their previous 24-hour diet, refrain from alcohol, caffeine, and exercise for 24 hours and fast for 10 hours prior to each of the treatments.
• Participant agrees to maintain existing dietary and physical activity patterns throughout the study period.
• Participant is willing and able to comply with the study protocol.

Exclusion Criteria:

• A history of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
• The participant's alcohol consumption is more than two standard alcoholic drinks per day or more than 10 drinks per week or has a history of drug/alcohol abuse or dependence.
• History of diabetes (any form) or any endocrine disorder.
• Fasting blood sugar of > 125 mg/dL.
• Current smokers or smoking cessation within the past month (28 days).
• History of hyperparathyroidism or an untreated thyroid disease.
• History of malignancy in the previous five years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Any history of gastrointestinal bypass surgery, etc., or any known functional gastrointestinal disorder that may impact nutrient absorption, e.g., short bowel syndrome, atrophic gastritis, IBD, diarrheal illnesses, history of colon resection, gastroparesis, gastric resection, celiac disease, or Inherited Errors of Metabolism (such as PKU).
• Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's Disease, ulcerative colitis, lupus, HIV/AIDS, etc.).
• History of using butyrate or tributyrin-containing dietary supplements within the past seven days.
• Known allergy or sensitivity to any ingredient in the test formulations as listed on the product label.
• Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lysine Butyrate	Dietary supplement: Lysine butyrate; Lysine butyrate supplement. This study will compare plasma pharmacokinetic profiles of three commercially available butyrate supplements.
Active Comparator: Sodium buytrate	Dietary supplement: Sodium Butyrate; Oral sodium butyrate supplement.
Active Comparator: Tributyrin	Dietary supplement: Tributyrin; Oral tributyrin supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma butyrate levels	Plasma butyrate levels in ug/mL.	Prior to product administration (time 0), as well as 20, 45, 90, 150, and 210 minutes post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scales for cognitive function.	Cognitive function as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better cognitive function.	0, 20, 45, 90, 150 and 210 minutes post-dose
Visual analog scales for mood.	Mood as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mood.	0, 20, 45, 90, 150 and 210 minutes post-dose

Collaborators and Investigators

• Sponsor: The Center for Applied Health Sciences, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Actual): July 16, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Butyric Acid
• Other Study ID Numbers: BUTY-0324-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No