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This study is a randomized, three-arm, interventional study of N=10 apparently healthy men. This study will quantify plasma butyrate responses to a single dose of three different butyrate products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lysine Butyrate | Experimental |
| |
| Sodium buytrate | Active Comparator |
| |
| Tributyrin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lysine butyrate | Dietary Supplement | Lysine butyrate supplement. This study will compare plasma pharmacokinetic profiles of three commercially available butyrate supplements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma butyrate levels | Plasma butyrate levels in ug/mL. | Prior to product administration (time 0), as well as 20, 45, 90, 150, and 210 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scales for cognitive function. | Cognitive function as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better cognitive function. | 0, 20, 45, 90, 150 and 210 minutes post-dose |
| Visual analog scales for mood. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C033017 | lysine butyrate |
| D020148 | Butyric Acid |
| C005830 | tributyrin |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Sodium Butyrate | Dietary Supplement | Oral sodium butyrate supplement. |
|
| Tributyrin | Dietary Supplement | Oral tributyrin supplement. |
|
Mood as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mood. |
| 0, 20, 45, 90, 150 and 210 minutes post-dose |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |