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| Name | Class |
|---|---|
| Young Living Essential Oils | UNKNOWN |
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The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.
After being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. Those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be assessed at baseline, on day 30 and on day 60.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants consume 2 ounces of the supplement each morning for 60 days. |
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| Control | No Intervention | Participants do not make any changes to their health related routines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement Drink | Dietary Supplement | Superfoods based nutritional supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60 | The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items. | Baseline and day 60 |
| Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60 | The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items. | Baseline and day 60 |
| Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60 | The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items. | Baseline and day 60 |
| Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60. | The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.) | Day 60 |
| Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60 | The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items. | Baseline and Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie Hawkins, PhD | Nutraceuticals Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin School of Integrative Health Sciences | Franklin | Tennessee | 37067 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| D012816 | Signs and Symptoms |