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| Name | Class |
|---|---|
| Biofortis Mérieux NutriSciences | OTHER |
| University of Arkansas | OTHER |
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The aim is to determine the bioavailability of the polyphenol fraction form a commercially available hemp hull fiber at two different amounts in generally healthy adults. Additional objectives include determining specific metabolites produced over a 24 to 48-hour period following the hemp fiber consumption. Subjects will consume a study pudding that will be used to deliver a low and a high dose fiber product. Blood samples will be collected to measure background levels of metabolites. At day 0 participants will consume a low dose study product and day 6 the high dose study product and provide blood samples over an 8 hr period after study product consumption, to be followed by a 24 hr blood sample and 48 hr blood sample. Additionally following the low / high dose study product 24 and 48 h urine samples will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose fiber | Active Comparator | Dose esacalation design |
|
| High dose of fiber | Active Comparator | Dose escalation design which is one arm with low and followed by high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose dietary fiber | Dietary Supplement | Subjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of phenolics from 0 to 8 hours | 0 to 8 hours after consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of phenolics 0 to 24 hours | 0 to 24 hours after consumption | |
| Urine concentration of phenolics 24 and 48 hours after consumption | cumulative total phenolics at 24 and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Addison | Illinois | 60101 | United States |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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Participants receive same treatment in dose escalation design
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| High dose dietary fiber | Dietary Supplement | Subjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design |
|
| Concentration of Phenolic metabolites in blood and urine | Blood concnetrations at 0 to 8 hours post consumption and cumulative urine concentration 24 hours and 48 hours post consumption |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |