Immune
Conditions
Brief summary
Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement.
Interventions
DIETARY_SUPPLEMENTAmunizer
12 oz. herbal, probiotic and antioxidant herbal beverage
OTHERPlacebo
12 oz. flavored beverage
Sponsors
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\-
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with symptoms documented by the Franklin Health Immune Inventory (FHII) | from baseline to the end of the study, 8 weeks | 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. |
| Severity of symptoms documented by the FHII | from baseline to the end of the study, 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity on the dermal symptom subscale of the FHII | from baseline to the end of the study, 8 weeks | The FHII subscale measures 9 dermal symptoms on a likert scale with higher scores indicating greater severity. |
| Change from baseline scores on the Franklin Energy Level Inventory | 8 week | The Franklin Energy Level Inventory measures signs of energy across 6 subdomains, with higher scores indicating greater levels of energy. |
| Incidence and severity on the upper respiratory symptom subscale of the FHII | from baseline to the end of the study, 8 weeks | The FHII subscale measures 16 respiratory symptoms on a likert scale with higher scores indicating greater severity. |
| Change from baseline scores on the Franklin Mood Scale | 8 week | The Franklin Mood Scale measures mood stats across 4 subdomains, with higher scores indicating improvements to mood. |
| Change from baseline scores on the Franklin Sleep Quality Inventory | 8 week | The Franklin Sleep Quality Inventory measures sleep quality across 7 subdomains, with higher scores indicating higher quality sleep. |
| Incidence and severity on the gastrointestinal symptom subscale of the FHII | from baseline to the end of the study, 8 weeks | The FHII subscale measures 11 gastrointestinal symptoms on a likert scale with higher scores indicating greater severity. |
Countries
United States
Outcome results
None listed