A Pharmacokinetic Comparison of Three Butyrate Products
NCT ID: NCT06700785
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2024-05-03
2024-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Lysine Butyrate
Lysine butyrate
Lysine butyrate supplement. This study will compare plasma pharmacokinetic profiles of three commercially available butyrate supplements.
Sodium buytrate
Sodium Butyrate
Oral sodium butyrate supplement.
Tributyrin
Tributyrin
Oral tributyrin supplement.
Interventions
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Lysine butyrate
Lysine butyrate supplement. This study will compare plasma pharmacokinetic profiles of three commercially available butyrate supplements.
Sodium Butyrate
Oral sodium butyrate supplement.
Tributyrin
Oral tributyrin supplement.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
45 Years
MALE
Yes
Sponsors
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The Center for Applied Health Sciences, LLC
INDUSTRY
Responsible Party
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Locations
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The Center for Applied Health Sciences
Canfield, Ohio, United States
Countries
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Other Identifiers
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BUTY-0324-01
Identifier Type: -
Identifier Source: org_study_id
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