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The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.
Participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition will provide information on effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant Extract 1 | Experimental | Participants in this arm will take an ashwagandha root supplement each day for 60 days. |
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| Plant Extract 2 | Experimental | Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days. |
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| Placebo | Placebo Comparator | Participants in this arm will take an inert placebo each day for 60 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ashwagandha root | Dietary Supplement | This substance is extracted from the root of the plant. |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-test Cortisol Awakening Response, after controlling for baseline scores | salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score | 60 days |
| NRI-SS (Nutraceuticals Research Institute's Stress Scale) | This is a validated scale measuring 6 subdomains of stress. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater stress levels. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| NRI-ES (Nutraceuticals Research Institute's Energy Scale) | This is a validated scale measuring 6 subdomains of energy. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater energy levels. | 60 days |
| NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale) |
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Inclusion Criteria:
Exclusion Criteria:
biological sex of woman; gender identification of female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessie Hawkins, PhD | Contact | 256-203-9010 | j.hawkins@nutraceuticalsresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutraceuticals Research Institute | Recruiting | Huntsville | Alabama | 35801 | United States |
Consent to share IPD will not been obtained from participants.
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ashwagandha root and leaf | Dietary Supplement | This substance is extracted from both the root and leaves of the plant. |
|
| placebo | Other | The inert placebo does not contain any of the plant matter. |
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This is a validated scale measuring 7 subdomains of sleep. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of sleep |
| 60 days |
| NRI-Cognition Scale | This is a validated scale measuring 6 subdomains of cognition. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of cognitive health | 60 days |