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This research study is being done to assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kava Group | Experimental | Subjects will receive Kavalactones for 28 days |
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| Placebo Group | Placebo Comparator | Subjects will receive placebo for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kavalactones | Dietary Supplement | Three 75 mg capsules orally once daily within one hour of bedtime (225 mg total/day) |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cortisol | Blood serum cortisol levels reported in micrograms per deciliter (mcg/dL) | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in burnout | Measured using the Maslach Burnout Inventory-Human Services Survey for Medical Personnel - MBI-HSS (MP): The MBI-HSS (MP) addresses three scales: Emotional Exhaustion measures feelings of being emotionally overextended and exhausted by one's work; Depersonalization measures an unfeeling and impersonal response toward patients; Personal Accomplishment measures feelings of competence and successful achievement in one's work. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brent Bauer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Placebo | Drug | Three capsules orally once daily within one hour of bedtime. Looks exactly like the study drug, but it contains no active ingredient. |
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| Baseline, 4 weeks |
| Change in motivation | Measured using the Cravings for Rest and Volitional Energy Expenditure (CRAVE) survey developed to measure motivation states for physical activity and sedentary behaviors. Subjects indicate how much they want or desire to perform activities by circling the number along each line between 0 (not at all) and 10 (more than ever). | Baseline, 4 weeks |
| Change in mood | Measured using the Depression, Anxiety and Stress Scale - 21 Items (DASS-21). The DASS-21 is a non-diagnostic, validated instrument to assess perceived levels of depressed, stressed, or anxious emotional states over the past seven days. Scores for each state range from 0-42 and can be summed to generate a total score reflecting overall negative mood. | Baseline, 4 weeks |
| Change in sleep | Measured using the PROMIS Sleep Disturbance -Short Form 6a to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. | Baseline, 4 weeks |
| Change in quality of life | Measured using the Linear Analogue Self-Assessment (LASA) - LASA-1 single item Likert scale of 10 points (0-10) which measures quality of life, with higher score indicating better quality of life. | Baseline, 4 weeks |
| Change in stress | Measured using The Perceived Stress Scale-10 (PSS) that elicits self-reported personal stress levels. The scores range from 0-40, with higher scores indicating more severe stress. | Baseline, 4 weeks |
| Change in cognition | Measured using CNS Vital Signs in-office neurocognitive testing, a non-invasive clinical procedure to efficiently and objectively assess a broad spectrum of brain function performance or domains under challenge (cognition stress test). | Baseline, 4 weeks |
| Adverse events | Number of adverse events reported | 4 weeks |