Tributyrin: Time Course & Efficacy to Improve Health & Performance

Not Applicable

Terminated

• Conditions: Inflammation; Performance; Metabolite Concentration; Gut Permeability; Sleep
• Interventions: Dietary Supplement: CoreBiome; Dietary Supplement: Placebo

• Registration Number: NCT06501898
• Lead Sponsor: Florida State University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-08-19
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CoreBiome	CoreBiome	Participants will be given tributyrin (as CoreBiome)
Placebo	Placebo	Participants will be given a taste-, color-, and odor-matched placebo

Primary Outcome Measures

Name	Time	Method
Metabolite Concentration	2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation	Fecal butyrate concentration

Secondary Outcome Measures

Name	Time	Method
Sleep quantity	Four weeks prior to day of exercise bout	Sleep duration
Gut permeability	10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)	Urine dual sugar absorption, Plasma sCD14
Inflammation	10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)	Whole-body inflammation (IL-6 and IL-10) and gut-specific inflammation (IL-17 and IL-23)
Sleep Quality	Four weeks prior to day of exercise bout	Number of sleep disturbances
Maximum sprint power (mid-exercise)	During exercise bout	Maximum power quantification during cycling exercise
Substrate Utilization (mid-exercise)	During exercise bout	Respiratory exchange ratio assessment via metabolic testing during cycling exercise
Immune cell composition	10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)	Relative proportions of serum immune cells (e.g., macrophages, neutrophils, T cells, B cells, etc.)
Average sprint power (mid-exercise)	During exercise bout	Average power quantification during cycling exercise
Perceived exertion (mid-exercise)	During exercise bout	Subjective perceived exertion survey during cycling exercise
Total completed distance (mid-exercise)	During exercise bout	Total completed distance during cycling exercise

Trial Locations

Locations (1)

Institute of Sports Sciences & Medicine; 🇺🇸 Tallahassee, Florida, United States