Tributyrin for Health and Performance

(CoreBiome Trial)

Overseen By Michael Ormsbee

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Microbiome supplements

Disqualifiers: Metabolic, cardiovascular, gastrointestinal, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement called tributyrin can enhance health and performance in individuals who are not very active. It examines how tributyrin might improve gut and immune health, sleep, and exercise performance while reducing inflammation. Participants will take either a tributyrin supplement or a placebo (a look-alike without active ingredients) for four weeks, with various health assessments conducted throughout the study. Those who exercise less than 150 minutes a week may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve personal health outcomes.

Do I have to stop taking my current medications?

The protocol does not specify if you need to stop taking your current medications. However, you cannot take supplements that impact the microbiome, hydration, core temperature, or exercise performance.

Is there any evidence suggesting that tributyrin is likely to be safe for humans?

Research has shown that tributyrin, particularly in its CoreBiome form, is generally safe. Studies have found that CoreBiome can be absorbed in the colon, which benefits gut health. Experts consider tributyrin GRAS (Generally Recognized as Safe), indicating its safety for intended use.

Tributyrin has been studied for various health benefits, including gut health and weight management. Although specific side effects are not detailed in the sources, its GRAS status suggests serious side effects are unlikely. However, individual reactions can vary, so staying informed and consulting healthcare providers if concerns arise is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Tributyrin is unique because it introduces a different approach to enhancing health and performance by targeting gut health directly. Unlike many current treatments that focus on symptoms, tributyrin acts as a source of butyrate, a short-chain fatty acid that supports gut lining integrity and reduces inflammation. Researchers are excited about tributyrin because it could offer a natural way to improve gut health, which might translate into better overall health and athletic performance. This potential makes it a promising alternative to standard dietary supplements and medications that often do not address the root cause of gut-related issues.

What evidence suggests that tributyrin might be an effective treatment for improving health and performance?

Studies have shown that tributyrin, which participants in this trial may receive as CoreBiome, can improve gut health and strengthen the immune system. Research indicates that it also supports the growth of beneficial gut bacteria, potentially enhancing digestion and nutrient absorption. In animal studies, tributyrin improved growth, suggesting similar benefits for human health and performance. Additionally, tributyrin increases butyrate levels in the gut, which can reduce inflammation and improve overall health. These findings suggest that tributyrin could effectively enhance various health markers. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for sedentary men and women who may have metabolic disorders, leaky gut syndrome, inflammation issues, sleep disturbances or performance anxiety. Participants will be required to take supplements and undergo various health assessments over a 4-week period.

Inclusion Criteria

Sedentary (<150 minutes of aerobic exercise per week)

I am between 30 and 50 years old.

Exclusion Criteria

Experienced previous heat illness

Known injuries that limit exercise

BMI ≥ 40 kg/m^2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tributyrin supplementation for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tributyrin

Trial Overview The study tests whether tributyrin (CoreBiome) can improve metabolite concentrations, overall health biomarkers, and performance compared to a placebo. It involves fecal metabolite measures, cardiovascular evaluation, sleep assessment, exercise testing and blood samples.

How Is the Trial Designed?

Group I: CoreBiome Active Control 1 Intervention

Participants will be given tributyrin (as CoreBiome)

Group II: Placebo Placebo Group 1 Intervention

Participants will be given a taste-, color-, and odor-matched placebo

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Compound Solutions Inc.

Collaborator

Trials

5

Recruited

250+

Compound Solutions Inc.

Industry Sponsor

Trials

5

Recruited

250+

Published Research Related to This Trial

Tributyrin supplementation in sows significantly shortened the total parturition time and reduced the diarrhea rate in suckling piglets, indicating improved reproductive performance and health outcomes.

The addition of tributyrin increased the diversity of gut microbiota in both sows and piglets, enhancing levels of beneficial bacteria like Lactobacillus, which may contribute to better immune responses and milk composition during lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal tributyrin supplementation in late pregnancy and lactation improves offspring immunity, gut microbiota, and diarrhea rate in a sow model. Lin, Y., Li, D., Ma, Z., et al.[2023]

In a study involving 65 men with abnormal semen quality, treatment with Tribulus terrestris significantly improved sperm concentration, motility, and liquefaction time, indicating its potential as a therapeutic option for male infertility.

The treatment also led to a decrease in body fat percentage and an increase in lean muscle mass, alongside elevated levels of dihydrotestosterone, suggesting that Tribulus terrestris may enhance overall male reproductive health through its action on hormone levels and testicular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of oral administration of Tribulus terrestris extract on semen quality and body fat index of infertile men. Salgado, RM., Marques-Silva, MH., Gonçalves, E., et al.[2018]

Tributyrin, when added to the diet of weaning piglets at a concentration of 0.2%, significantly altered gut microbiota composition, increasing beneficial bacterial genera associated with growth performance.

The changes in gut microbiota were linked to improved average daily gain and body weight in piglets, suggesting that tributyrin may enhance energy metabolism while reducing carbohydrate metabolism, contributing to better growth outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of Tributyrin on Gut Microbiota Shifts Related to Performances of Weaning Piglets. Miragoli, F., Patrone, V., Prandini, A., et al.[2021]

Tributyrin, a prodrug of butyrate, was found to be more effective than natural butyrate in inhibiting growth and promoting differentiation in Caco-2 colon cancer cells, suggesting it could be a better therapeutic option.

The combination of tributyrin and dihydroxycholecalciferol (a form of vitamin D) enhanced the effects on cancer cell growth and differentiation by increasing the expression of the vitamin D receptor, indicating a potential synergistic approach for colorectal cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tributyrin, a stable and rapidly absorbed prodrug of butyric acid, enhances antiproliferative effects of dihydroxycholecalciferol in human colon cancer cells. Gaschott, T., Steinhilber, D., Milovic, V., et al.[2018]

In a study of 70 aging males with erectile dysfunction, those who took Tribulus terrestris for 3 months showed significant increases in testosterone levels and improved erectile function, as measured by a validated index.

Despite some elevations in liver enzymes and prostate-specific antigen, there were no negative effects on lower urinary tract symptoms, indicating that Tribulus terrestris may be a safe option for improving sexual health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tribulus terrestris versus placebo in the treatment of erectile dysfunction and lower urinary tract symptoms in patients with late-onset hypogonadism: A placebo-controlled study. GamalEl Din, SF., Abdel Salam, MA., Mohamed, MS., et al.[2019]

In a study involving 15 resistance-trained males over 8 weeks, supplementation with Tribulus terrestris did not lead to significant changes in body composition or mood states compared to a placebo.

While the placebo group showed improvements in muscle endurance for both bench and leg press exercises, the tribulus group only demonstrated a significant increase in leg press strength, indicating that tribulus may not enhance overall exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Tribulus terrestris on body composition and exercise performance in resistance-trained males. Antonio, J., Uelmen, J., Rodriguez, R., et al.[2022]

Tribulus terrestris L. contains a variety of active compounds, including sterol saponins and flavonoids, which are believed to have potential health benefits for conditions like infertility, low libido, and diabetes, but the effectiveness can vary widely due to differences in composition and extraction methods.

Research on Tribulus terrestris has produced mixed results regarding its efficacy and safety, indicating a need for standardized extracts and further studies to confirm its pharmacological mechanisms and therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review of the Phytochemical, Pharmacological, and Toxicological Properties of Tribulus terrestris L. Ștefănescu, R., Tero-Vescan, A., Negroiu, A., et al.[2023]

Tribulus terrestris has a long history of use in traditional medicine for treating various conditions, particularly infertility and loss of libido, due to its active compounds like flavonoids and saponins.

The plant exhibits multiple pharmacological activities, including anti-inflammatory, antimicrobial, and antioxidant effects, suggesting its potential for broader therapeutic applications and warranting further research into its health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phytopharmacology of Tribulus terrestris. Shahid, M., Riaz, M., Talpur, MM., et al.[2017]

Tributyrin effectively inhibits the growth of human gastric cancer SGC-7901 cells in a dose- and time-dependent manner, significantly reducing DNA synthesis after 48 hours of treatment.

The mechanism of action involves inducing apoptosis in the cancer cells, as evidenced by changes in protein expression (decreased Bcl-2 and increased Bax), suggesting that tributyrin could be a promising agent for preventing and treating gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tributyrin inhibits human gastric cancer SGC-7901 cell growth by inducing apoptosis and DNA synthesis arrest. Yan, J., Xu, YH.[2019]

Tributyrin supplementation in yellow-feathered broilers improved growth performance, as indicated by a better feed conversion ratio and increased final weight compared to the control group, based on a study involving 360 chicks over 63 days.

The treatment with tributyrin also positively altered the intestinal microbiota, increasing beneficial bacteria like Bacteroidetes and correlating with improved feed efficiency, suggesting a mechanism of action through modulation of gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dietary Tributyrin on Growth Performance, Biochemical Indices, and Intestinal Microbiota of Yellow-Feathered Broilers. Gong, L., Xiao, G., Zheng, L., et al.[2021]

Tributyrin and butyrate both effectively reduced the growth of human pancreatic cancer cells, with tributyrin showing a lower IC50 value (1.1 mmol/L) compared to butyrate (3.6 mmol/L), indicating it may be more potent.

Both compounds induced apoptosis and stimulated differentiation in pancreatic cancer cell lines, suggesting that tributyrin could be a promising therapeutic option for pancreatic cancer by achieving effective butyrate levels in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tributyrin, a butyrate precursor, impairs growth and induces apoptosis and differentiation in pancreatic cancer cells. Gaschott, T., Maassen, CU., Stein, J.[2012]

Tributyrin (TB) effectively inhibits the growth of HT-29 colon cancer cells in a dose-dependent manner, with an IC50 value of 1 mM, making it more potent than its active form, sodium butyrate, which has an IC50 of 2.2 mM.

TB not only suppresses cell proliferation but also promotes differentiation of cancer cells, as indicated by significant increases in the expression of markers like CEA and E-cadherin, suggesting its potential as a promising therapeutic agent for colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tributyrin induces growth inhibitory and differentiating effects on HT-29 colon cancer cells in vitro. Schröder, C., Eckert, K., Maurer, HR.[2019]

The study successfully encapsulated tributyrin (TB) with gamma-cyclodextrin (CD) using spray-drying, resulting in a complex that retains TB effectively and shows a crystalline structure, indicating a stable formulation.

In vitro tests demonstrated that the TB/CD complex significantly increased butyrate production in the ileum and ascending colon, suggesting its potential use in food applications to enhance gut health by delivering butyrate more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encapsulation of tributyrin by gamma-cyclodextrin: Complexation, spray drying, and in vitro fermentation. Shi, X., Monaco, MH., Donovan, SM., et al.[2021]

In a study with diet-induced obese mice, treatment with tributyrin, a prodrug of butyrate, resulted in lower body weight gain and improved insulin sensitivity and glucose metabolism over six weeks.

Tributyrin treatment also led to an anti-inflammatory effect in adipose tissue, reducing pro-inflammatory markers and increasing anti-inflammatory markers, suggesting that targeting SCFA butyrate could be a promising strategy for addressing obesity-related metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tributyrin Attenuates Metabolic and Inflammatory Changes Associated with Obesity through a GPR109A-Dependent Mechanism. Sato, FT., Yap, YA., Crisma, AR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06501898

Tributyrin: Time Course & Efficacy to Improve Health & ... The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7222802/

Effects of Tributyrin Supplementation on Growth ... Tributyrin showed the ability to promote gut health, to modulate gut microbiota and to improve protein digestibility, leading also to higher growth performance.

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1712993/full

Tributyrin (CoreBiome®) enhances butyrate levels and ... Using the SHIME® model, it was shown that three weeks of daily tributyrin supplementation had a butyrogenic effectincreased butyrate levels and ...

4. jandonline.org jandonline.org/article/S2212-2672(21)00451-2/fulltext

Effects of 3-week Tributyrin Supplementation on the Gut ... Tributyrin, a butyrate prodrug, has been proven to overcome the pharmacokinetic drawbacks of butyrate with potential health benefits.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268005X23010512

Tributyrin microcapsule prepared by ultrahigh ... As a feed additive, tributyrin was proven to improve the growth performance of piglets. In addition, tributyrin displays excellent biocompatibility, making it a ...

6. amazon.com amazon.com/Peak-Performance-Corebiome-Tributyrin-Postbiotics/dp/B0B194KJ92

CoreBiome Tributyrin Postbiotic Supplement Clinically ... Peak Performance Tributyrin CoreBiome is the “better butyrate” for gut health. A clinical study showed CoreBiome achieves bioavailability in the colon.

7. compoundsolutions.com compoundsolutions.com/ingredients/corebiome/

CoreBiome® - Our #1 Postbiotic from Compound Solutions Patented · GRAS (Generally Recognized as Safe) · Made in the USA · Made from fermented sources · Clinically shown bioavailable butyrate · Available in power or ...

8. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Tributyrin

Tributyrin | C15H26O6 | CID 6050 - PubChem - NIH Tributyrin has been used in trials studying the treatment of Prostate Cancer and Unspecified Adult Solid Tumor, Protocol Specific. DrugBank. Tributyrin has been ...

9. prinovaglobal.com prinovaglobal.com/eu/en/ingredients/branded-ingredients/compound-solutions/corebiome

CoreBiome CoreBiome is a foundational gut ingredient, the first tributyrin with colon bioavailability, that may help with gut wellness, bloating, and weight management.