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| Name | Class |
|---|---|
| Compound Solutions Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoreBiome | Active Comparator | Participants will be given tributyrin (as CoreBiome) |
|
| Placebo | Placebo Comparator | Participants will be given a taste-, color-, and odor-matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoreBiome | Dietary Supplement | 300 mg, once daily of tributyrin for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite Concentration | Fecal butyrate concentration | 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Gut permeability | Urine dual sugar absorption, Plasma sCD14 | 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise) |
| Inflammation | Whole-body inflammation (IL-6 and IL-10) and gut-specific inflammation (IL-17 and IL-23) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Sports Sciences & Medicine | Tallahassee | Florida | 32301 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005830 | tributyrin |
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| Placebo | Dietary Supplement | 300 mg, once daily of placebo for 4 weeks |
|
| 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise) |
| Immune cell composition | Relative proportions of serum immune cells (e.g., macrophages, neutrophils, T cells, B cells, etc.) | 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise) |
| Sleep Quality | Number of sleep disturbances | Four weeks prior to day of exercise bout |
| Sleep quantity | Sleep duration | Four weeks prior to day of exercise bout |
| Substrate Utilization (mid-exercise) | Respiratory exchange ratio assessment via metabolic testing during cycling exercise | During exercise bout |
| Perceived exertion (mid-exercise) | Subjective perceived exertion survey during cycling exercise | During exercise bout |
| Total completed distance (mid-exercise) | Total completed distance during cycling exercise | During exercise bout |
| Maximum sprint power (mid-exercise) | Maximum power quantification during cycling exercise | During exercise bout |
| Average sprint power (mid-exercise) | Average power quantification during cycling exercise | During exercise bout |