Gastro-Intestinal DisorderNCT06700785
A Pharmacokinetic Comparison of Three Butyrate Products
A study testing Lysine butyrate, Sodium Butyrate and Tributyrin in people with Gastro-Intestinal Disorder, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Disorder
- What is being tested?
- Lysine butyrate, Sodium Butyrate and Tributyrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
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.
- Conditions
- Gastro-Intestinal Disorder
- Being tested
- Lysine butyrate, Sodium Butyrate, Tributyrin
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysine butyrateDietary supplement
Lysine butyrate supplement. This study will compare plasma pharmacokinetic profiles of three commercially available butyrate supplements.
Sodium ButyrateDietary supplement
Oral sodium butyrate supplement.
TributyrinDietary supplement
Oral tributyrin supplement.
| Study group | Role | What they receive |
|---|---|---|
| Lysine Butyrate | Experimental | Not described Receives: Dietary Supplement: Lysine butyrate |
| Sodium buytrate | Active comparator | Not described Receives: Dietary Supplement: Sodium Butyrate |
| Tributyrin | Active comparator | Not described Receives: Dietary Supplement: Tributyrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma butyrate levels
Plasma butyrate levels in ug/mL.
Measured: Prior to product administration (time 0), as well as 20, 45, 90, 150, and 210 minutes post-dose
Secondary outcomes (2)
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.
Measured: 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.
Measured: 0, 20, 45, 90, 150 and 210 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start3 May 2024
- Primary completion16 Jul 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700785
- Sponsor's protocol ID
- BUTY-0324-01
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Comparison of Three Butyrate Products
- ClinicalTrials.gov ID
- NCT06700785
- Acronym / sponsor ID
- BUTY-0324-01
- Conditions
- Gastro-Intestinal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lysine Butyrate | Experimental | Dietary Supplement: Lysine butyrate |
| Sodium buytrate | Active comparator | Dietary Supplement: Sodium Butyrate |
| Tributyrin | Active comparator | Dietary Supplement: Tributyrin |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lysine butyrateLysine butyrate supplement. This study will compare plasma pharmacokinetic profiles of three commercially available butyrate supplements. | Dietary supplement | Lysine Butyrate |
| Sodium ButyrateOral sodium butyrate supplement. | Dietary supplement | Sodium buytrate |
| TributyrinOral tributyrin supplement. | Dietary supplement | Tributyrin |
Primary outcome
plasma butyrate levels
Time frame: Prior to product administration (time 0), as well as 20, 45, 90, 150, and 210 minutes post-dose
Plasma butyrate levels in ug/mL.
2 secondary outcomes
Visual analog scales for cognitive function.
Time frame: 0, 20, 45, 90, 150 and 210 minutes post-dose
Visual analog scales for mood.
Time frame: 0, 20, 45, 90, 150 and 210 minutes post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lysine butyrate, Sodium Butyrate and Tributyrin in people with Gastro-Intestinal Disorder, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma butyrate levels (time frame: Prior to product administration (time 0), as well as 20, 45, 90, 150, and 210 minutes post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.