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Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Herbal and probiotic beverage |
|
| Placebo | Placebo Comparator | Similar beverage without the probiotics and botanicals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amunizer | Dietary Supplement | 12 oz. herbal, probiotic and antioxidant herbal beverage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with symptoms documented by the Franklin Health Immune Inventory (FHII) | The FHII measures incidence and severity of over 50 signs of immune health. Days with symptoms will range from 0 to 56 days, indicating no sickness to sick every day. | from baseline to the end of the study, 8 weeks |
| Severity of symptoms documented by the FHII | The FHII measures incidence and severity of over 50 signs of immune health. Symptom severity is measured on a likert scale with higher scores indicating greater symptom severity. | from baseline to the end of the study, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity on the upper respiratory symptom subscale of the FHII | The FHII subscale measures 16 respiratory symptoms on a likert scale with higher scores indicating greater severity. | from baseline to the end of the study, 8 weeks |
| Incidence and severity on the gastrointestinal symptom subscale of the FHII |
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Inclusion Criteria:
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin Health Research Center | Franklin | Tennessee | 37067 | United States |
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| Placebo |
| Other |
12 oz. flavored beverage |
|
The FHII subscale measures 11 gastrointestinal symptoms on a likert scale with higher scores indicating greater severity. |
| from baseline to the end of the study, 8 weeks |
| Incidence and severity on the dermal symptom subscale of the FHII | The FHII subscale measures 9 dermal symptoms on a likert scale with higher scores indicating greater severity. | from baseline to the end of the study, 8 weeks |
| Change from baseline scores on the Franklin Energy Level Inventory | The Franklin Energy Level Inventory measures signs of energy across 6 subdomains, with higher scores indicating greater levels of energy. | 8 week |
| Change from baseline scores on the Franklin Sleep Quality Inventory | The Franklin Sleep Quality Inventory measures sleep quality across 7 subdomains, with higher scores indicating higher quality sleep. | 8 week |
| Change from baseline scores on the Franklin Mood Scale | The Franklin Mood Scale measures mood stats across 4 subdomains, with higher scores indicating improvements to mood. | 8 week |