Tributyrin: Time Course & Efficacy to Improve Health & Performance

NCT ID: NCT06501898

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2025-03-01

Brief Summary

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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

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Conditions

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Metabolite Concentration Gut Permeability Inflammation Sleep Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CoreBiome

Participants will be given tributyrin (as CoreBiome)

Group Type ACTIVE_COMPARATOR

CoreBiome

Intervention Type DIETARY_SUPPLEMENT

300 mg, once daily of tributyrin for 4 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

300 mg, once daily of placebo for 4 weeks

Interventions

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CoreBiome

300 mg, once daily of tributyrin for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

300 mg, once daily of placebo for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Tributyrin

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Compound Solutions Inc.

INDUSTRY

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Ormsbee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Sports Sciences & Medicine

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004764

Identifier Type: -

Identifier Source: org_study_id

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