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| Name | Class |
|---|---|
| Aspen Clinical Research | OTHER |
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Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitality product AM + Vitality product PM | Experimental | Dietary Supplement: Proprietary blend of ginseng, cordyceps, and pomegranate + proprietary blend of broccoli seed, red orange, and grape seed taken twice a day for 8 weeks. |
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| Placebo | Placebo Comparator | Dietary Supplement: Placebo Placebo taken twice a day for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitality product AM + Vitality product PM | Dietary Supplement | Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine effects of investigational supplement on gene expression profiles. | Gene Expression Panel (microarray PBMCs), Inflammatory Panel, Oxidative stress Markers-including glutathione panel and F2 isoprostane, Anti-oxidant panel, and Lipid Panel | Day 0, Day 28, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Establish a safety profile of investigational supplement | Measure number of participants with adverse events. Fasted Safety Labs (chemistry, hematology, Coagulation)compared to baseline. | Day 0, Day 28, Day 56 |
| Determine effects of investigational supplement on markers of inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Harris, DO | Aspen Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aspen Clinical Research | Orem | Utah | 84058 | United States |
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| Placebo | Dietary Supplement | Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days |
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| Day 0, Day 28, Day 56 |
| Determine effects of investigational supplement on composite cognitive index | Day 0, Day 28, Day 56 |
| Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale) | Questionnaire: Hospital Anxiety and Depression Scale (HADS) | Day 0, Day 28, Day 56 |
| Determine changes in Quality of Life | SF-36 (Quality of Life Assessment) | Day 0, Day 28, Day 56 |
| Determine changes in sleep patterns and quality | Sleep measurement scale. | Day 0, Day 28, Day 56 |
| Determine changes to overall health | Abbreviated Physical Exam | Day 0, Day 28, Day 56 |
| Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA) | Digital Pulse Wave Analyzer | Day 0, Day 28, Day 56 |
| Determine changes in Biophotonic Scanner Scores | Measure antioxidants in the palm of the skin. | Day 0, Day 28, Day 56 |
| Determine changes in skin advanced glycation endproducts (AGE) levels | AGE Reader | Day 0, Day 28, Day 56 |