A Pharmacokinetic Comparison of Three Butyrate Products

Not Applicable

Completed

• Conditions: Gastro-Intestinal Disorder

• Registration Number: NCT06700785
• Lead Sponsor: The Center for Applied Health Sciences, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-03
• Primary Completion: 2024-07-16
• Study Completion: 2024-09-12
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Visual analog scales for cognitive function.	0, 20, 45, 90, 150 and 210 minutes post-dose	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.
Visual analog scales for mood.	0, 20, 45, 90, 150 and 210 minutes post-dose	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.

Trial Locations

Locations (1)

The Center for Applied Health Sciences; 🇺🇸 Canfield, Ohio, United States