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The purpose for this protocol is to perform a double-blind, randomized, placebo-controlled, parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on physical and mental energy levels and overall wellness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prickly pear juice | Experimental | Prickly pear juice, 3 oz daily for 8 weeks. |
|
| Pear-flavored juice | Placebo Comparator | Pear-flavored juice, 3 oz daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prickly pear juice | Dietary Supplement | 3 ounces daily for 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated. | Baseline, 2 weeks, and 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion | Digital inclinometry for measuring mobility of neck, back, hips, knees, and shoulders. | Baseline and 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gitte Jensen | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
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A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.
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| Pear-flavored juice |
| Dietary Supplement |
3 ounces daily for 8 weeks. |
|