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This study is designed to evaluate the safety and tolerability of two distinct dietary supplement beverage formulations designed to maintain normal blood pressure. In this study, safety and tolerability will be assessed among otherwise healthy, normotensive individuals.
The objective of this study is to evaluate the safety of 2 dietary supplement beverage formulations in healthy, normotensive individuals. The study period will be 29 days in length, during which we will monitor and catalogue the blood pressure (BP), heart rate (HR), comprehensive metabolic panel (CMP), complete blood count (CBC), as well as self-reported side effects of all subjects on a daily basis. Note that each beverage will be evaluated at multiple doses: Beverage 1 will be monitored at a low, medium and high dose, where the medium and high dose is quantitatively twice (2X) and thrice (3X) the low dose (1X), respectively. Similarly, we will evaluate Beverage 2 at a low dose and high dose where the high dose is quantitatively twice (2X) of the low dose (1X). A placebo treatment will also be incorporated into this study as well. As such, there will be 6 groups in this study. Three subjects will be assigned to each treatment group for a total of 18 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | a placebo (microcrystalline cellulose) identical in size, shape and color to the treatment |
|
| Circulatory Beverage - low dose | Experimental | A beverage containing natural ingredients at a low dose |
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| Circulatory Beverage - medium dose | Experimental | A beverage containing natural ingredients at a medium dose |
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| Circulatory Beverage - high dose | Experimental | A beverage containing natural ingredients at a high dose |
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| TCM Beverage - low dose | Experimental | A traditional Chinese medicine-based beverage containing natural ingredients at a low dose |
|
| TCM Beverage - high dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment 1 | Dietary Supplement | A dietary supplement containing beet root extract, arginine and citrulline |
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| Measure | Description | Time Frame |
|---|---|---|
| Aggregate Adverse Symptom Score | An assessment of adverse symptoms categorized as either respiratory, cardiovascular, neurological or gastrointestinal. If symptoms present, they are rated on a scale from 1 to 10, with indicating very mild symptoms and 10 indicating very severe symptoms. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure assessment | An assessment of subjects' blood pressure throughout the 4-week study period. | 4 weeks |
| Heart rate monitoring | An assessment of subjects' heart rate throughout the 4-week study period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Levy, PhD | Contact | (801) 954-7783 | mark.levy@usanainc.com | |
| Rolando Maddela, MPH | Contact | (801) 954-7568 | rolando.maddela@usanainc.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark Levy, PhD | USANA Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USANA Health Sciences | Salt Lake City | Utah | 84120 | United States |
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single blind, placebo controlled
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A traditional Chinese medicine-based beverage containing natural ingredients at a high dose |
|
| Treatment 2 | Dietary Supplement | A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract |
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| Placebo | Dietary Supplement | a placebo supplement that is similar in appearance to treatment 1 |
|
| 4 weeks |