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| Name | Class |
|---|---|
| University of Memphis | OTHER |
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This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1S | Experimental | Participants will consume 1 serving/day of the test product for 28 days. |
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| 2S | Experimental | Participants will consume 2 servings/day of the test product for 28 days |
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| 3S | Experimental | Participants will consume 3 servings/day of the test product for 28 days |
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| Placebo | Placebo Comparator | Participants will consume 1 serving/day of the placebo for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 serving of test product | Other | Participants will consume 1 serving/day of the test product for 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of test product | To assess the safety of the test product (TP) via comprehensive metabolic panel, complete blood count, urinalysis, vitals, and observed or reported adverse events. | 28 days |
| Tolerability of test product | To assess the tolerability of the test product via participant tolerability questionnaire. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bloomer, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Memphis | Memphis | Tennessee | 38152 | United States |
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| 2 servings of test product | Other | Participants will consume 2 servings/day of the test product for 28 days |
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| 3 servings of test product | Other | Participants will consume 3 servings/day of the test product for 28 days |
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| Placebo | Other | Participants will consume 1 serving/day of the placebo for 28 days |
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