Clinical trial NCT06700785: A Pharmacokinetic Comparison of Three Butyrate Products
Official title: A Pharmacokinetic Comparison of Three Butyrate Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Disorder
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 10
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: plasma butyrate levels
timeFrame: Prior to product administration (time 0), as well as 20, 45, 90, 150, and 210 minutes post-dose
Secondary outcomes:
measure: Visual analog scales for cognitive function.
timeFrame: 0, 20, 45, 90, 150 and 210 minutes post-dose
measure: Visual analog scales for mood.
timeFrame: 0, 20, 45, 90, 150 and 210 minutes post-dose
Other outcomes:
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
References: