Tributyrin: Time Course & Efficacy to Improve Health & Performance (CoreBiome)

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 Overview

• Status: Terminated
• Conditions: Inflammation; Sleep; Performance; Gut Permeability; Metabolite Concentration
• Intervention / Treatment: Dietary supplement: CoreBiome; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32301
      • Institute of Sports Sciences & Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age: 30-50 years
• Sedentary (<150 minutes of aerobic exercise per week)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CoreBiome; Participants will be given tributyrin (as CoreBiome)	Dietary supplement: CoreBiome; 300 mg, once daily of tributyrin for 4 weeks; Other Names: Tributyrin
Placebo Comparator: Placebo; Participants will be given a taste-, color-, and odor-matched placebo	Dietary supplement: Placebo; 300 mg, once daily of placebo for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolite Concentration	Fecal butyrate concentration	2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut permeability	Urine dual sugar absorption, Plasma sCD14	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)	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.)	10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
Sleep Quality	Number of sleep disturbances	Four weeks prior to day of exercise bout
Sleep quantity	Sleep duration	Four weeks prior to day of exercise bout
Substrate Utilization (mid-exercise)	Respiratory exchange ratio assessment via metabolic testing during cycling exercise	During exercise bout
Perceived exertion (mid-exercise)	Subjective perceived exertion survey during cycling exercise	During exercise bout
Total completed distance (mid-exercise)	Total completed distance during cycling exercise	During exercise bout
Maximum sprint power (mid-exercise)	Maximum power quantification during cycling exercise	During exercise bout
Average sprint power (mid-exercise)	Average power quantification during cycling exercise	During exercise bout

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: Compound Solutions Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: STUDY00004764

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No