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A Pharmacokinetic Comparison of Three Butyrate Products

NCT06700785•The Center for Applied Health Sciences, LLC

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

Age

25 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (1)

The Center for Applied Health Sciences

Canfield, Ohio, United States

Key Dates

Start Date

May 3, 2024

Primary Completion Date

July 16, 2024

Completion Date

September 12, 2024

Last Updated

November 22, 2024

Enrollment

ACTUAL participants

Conditions

Gastro-Intestinal Disorder

Interventions

Lysine butyrate

DIETARY_SUPPLEMENT

Sodium Butyrate

DIETARY_SUPPLEMENT

Tributyrin

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pharmacokinetic Comparison of Three Butyrate Products

Inclusion Criteria

Exclusion Criteria

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