Beverage for Immune Support

Study Overview
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Brief Summary
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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.

Official Title
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Amunizer for Immune Support: A Randomized, Placebo Controlled, Double Blind Clinical Trial

Conditions
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Immune

Intervention / Treatment
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* Dietary Supplement: Amunizer
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Herbal and probiotic beverage | Dietary Supplement: Amunizer<br>* 12 oz. herbal, probiotic and antioxidant herbal beverage<br>|
| Placebo Comparator: Placebo<br>Similar beverage without the probiotics and botanicals | Other: Placebo<br>* 12 oz. flavored beverage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |