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

Florida State University

Status: Terminated

Conditions: Performance; Inflammation; Metabolite Concentration; Gut Permeability; Sleep

Treatments: Dietary Supplement: Placebo; Dietary Supplement: CoreBiome

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06501898

STUDY00004764

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

CoreBiome

Active Comparator group

Description:

Participants will be given tributyrin (as CoreBiome)

Treatment:

Dietary Supplement: CoreBiome

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo