Tributyrin: Time Course & Efficacy to Improve Health & Performance

NCT06501898 | Terminated

• 1 other identifier: STUDY00004764
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolite Concentration; Gut Permeability; Inflammation; Sleep; Performance

Outcome Measures

Primary Outcomes (1)

• Metabolite Concentration

  Fecal butyrate concentration

  2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation

Secondary Outcomes (10)

• Gut permeability

  10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)

• Inflammation

  10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)

• Immune cell composition

  10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)

• Sleep Quality

  Four weeks prior to day of exercise bout

• Sleep quantity

  Four weeks prior to day of exercise bout

Study Arms (2)

CoreBiome

ACTIVE COMPARATOR

Participants will be given tributyrin (as CoreBiome)

Dietary Supplement: CoreBiome

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

CoreBiome DIETARY_SUPPLEMENT

300 mg, once daily of tributyrin for 4 weeks

Also known as: Tributyrin

CoreBiome

Placebo DIETARY_SUPPLEMENT

300 mg, once daily of placebo for 4 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• Compound Solutions Inc.: collaborator

Study Sites (1)

Institute of Sports Sciences & Medicine

Tallahassee, Florida, 32301, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

tributyrin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 15, 2024
• Study Start: August 19, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)