Metabolite ConcentrationCoreBiomeNCT06501898
Tributyrin: Time Course & Efficacy to Improve Health & Performance
A study testing CoreBiome in people with Metabolite Concentration and Gut Permeability, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolite Concentration, Gut Permeability, Inflammation
- What is being tested?
- CoreBiome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 1 Mar 2025
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 30-50 years
- Sedentary (<150 minutes of aerobic exercise per week)
Who cannot join
- Chronic, uncontrolled metabolic, cardiovascular, gastrointestinal, or hepatic disease
- Consumption of supplements known to impact the microbiome, hydration status, core temperature, or exercise performance
- Experienced previous heat illness
- Known injuries that limit exercise
- BMI ≥ 40 kg/m^2
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Sports Sciences & Medicine
Tallahassee, Florida, 32301
About this study
The purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. Participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.
- Conditions
- Metabolite Concentration, Gut Permeability, Inflammation, Sleep, Performance
- Being tested
- CoreBiome, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreBiomeDietary supplement
Also called Tributyrin
300 mg, once daily of tributyrin for 4 weeks
PlaceboDietary supplement
300 mg, once daily of placebo for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CoreBiome | Active comparator | Participants will be given tributyrin (as CoreBiome) Receives: Dietary Supplement: CoreBiome |
| Placebo | Placebo comparator | Participants will be given a taste-, color-, and odor-matched placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolite Concentration
Fecal butyrate concentration
Measured: 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation
Secondary outcomes (10)
Gut permeability
Urine dual sugar absorption, Plasma sCD14
Measured: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
Inflammation
Whole-body inflammation (IL-6 and IL-10) and gut-specific inflammation (IL-17 and IL-23)
Measured: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
Immune cell composition
Relative proportions of serum immune cells (e.g., macrophages, neutrophils, T cells, B cells, etc.)
Measured: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
Sleep Quality
Number of sleep disturbances
Measured: Four weeks prior to day of exercise bout
Sleep quantity
Sleep duration
Measured: Four weeks prior to day of exercise bout
Substrate Utilization (mid-exercise)
Respiratory exchange ratio assessment via metabolic testing during cycling exercise
Measured: During exercise bout
Perceived exertion (mid-exercise)
Subjective perceived exertion survey during cycling exercise
Measured: During exercise bout
Total completed distance (mid-exercise)
Total completed distance during cycling exercise
Measured: During exercise bout
Maximum sprint power (mid-exercise)
Maximum power quantification during cycling exercise
Measured: During exercise bout
Average sprint power (mid-exercise)
Average power quantification during cycling exercise
Measured: During exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start19 Aug 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolite ConcentrationStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Compound Solutions Inc.
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501898
- Sponsor's protocol ID
- STUDY00004764
- Acronym
- CoreBiome
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tributyrin: Time Course & Efficacy to Improve Health & Performance
- ClinicalTrials.gov ID
- NCT06501898
- Acronym / sponsor ID
- CoreBiome / STUDY00004764
- Conditions
- Metabolite Concentration, Gut Permeability, Inflammation, Sleep, Performance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Compound Solutions Inc.
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 15 Jul 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.
The purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. Participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoreBiome | Active comparator | Dietary Supplement: CoreBiomeParticipants will be given tributyrin (as CoreBiome) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will be given a taste-, color-, and odor-matched placebo |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 30-50 years
- Sedentary (<150 minutes of aerobic exercise per week)
Key exclusion criteria (6 listed)
- Chronic, uncontrolled metabolic, cardiovascular, gastrointestinal, or hepatic disease
- Consumption of supplements known to impact the microbiome, hydration status, core temperature, or exercise performance
- Experienced previous heat illness
- Known injuries that limit exercise
- BMI ≥ 40 kg/m^2
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 |
|---|---|---|
| CoreBiomeAlso: Tributyrin300 mg, once daily of tributyrin for 4 weeks | Dietary supplement | CoreBiome |
| Placebo300 mg, once daily of placebo for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Metabolite Concentration
Time frame: 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation
Fecal butyrate concentration
10 secondary outcomes
Gut permeability
Time frame: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
Inflammation
Time frame: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
Immune cell composition
Time frame: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
Sleep Quality
Time frame: Four weeks prior to day of exercise bout
Sleep quantity
Time frame: Four weeks prior to day of exercise bout
Substrate Utilization (mid-exercise)
Time frame: During exercise bout
Perceived exertion (mid-exercise)
Time frame: During exercise bout
Total completed distance (mid-exercise)
Time frame: During exercise bout
Maximum sprint power (mid-exercise)
Time frame: During exercise bout
Average sprint power (mid-exercise)
Time frame: During exercise bout
Results and safety
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
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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 CoreBiome in people with Metabolite Concentration and Gut Permeability, run by Florida State University 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Apr 2025. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Loss of funding). Results are not available in the source record.
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?
Metabolite Concentration (time frame: 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation). 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 13 Apr 2025.