Gut Permeability, Inflammation, Metabolite Concentration, Performance, Sleep
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCoreBiome
300 mg, once daily of tributyrin for 4 weeks
DIETARY_SUPPLEMENTPlacebo
300 mg, once daily of placebo for 4 weeks
Sponsors
Compound Solutions Inc.
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolite Concentration | 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation | Fecal butyrate concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average sprint power (mid-exercise) | During exercise bout | Average power quantification during cycling exercise |
| Substrate Utilization (mid-exercise) | During exercise bout | Respiratory exchange ratio assessment via metabolic testing 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 |
| Maximum sprint power (mid-exercise) | During exercise bout | Maximum power quantification during cycling exercise |
| 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) |
| 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.) |
| Sleep Quality | Four weeks prior to day of exercise bout | Number of sleep disturbances |
| 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 |
Countries
United States
Outcome results
None listed