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| Name | Class |
|---|---|
| Artemis International | UNKNOWN |
| IPRONA | UNKNOWN |
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The purpose of this study is to confirm and quantify the effects of ElderCraft® elderberry extract on immune health.
This study is a randomized double blind, placebo controlled clinical trial. The purpose is to evaluate the between-groups difference in incidence and duration of upper respiratory events and severity of upper respiratory symptoms while supplementing with ElderCraft® elderberry extract.
After attending an orientation session, participants will provide informed consent and be randomized on a 1:1 basis into an intervention group or a placebo group. Each group will consume two capsules daily for 13 weeks. Each intervention capsule contains 300 mg of European black elderberry extract, standardized to 15% anthocyanins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants will receive a 13-week supply of ElderCraft® (European black elderberry extract standardized to 15% anthocyanins). Each capsule contains 300mg of extract; participants will take a total of two capsules each day. |
|
| Placebo Arm | Placebo Comparator | Participants will receive a 13-week supply of inert placebo capsules matched for polysaccharide content. Participants will take a total of two capsules each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elderberry | Dietary Supplement | European black elderberry extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Upper Respiratory Symptomatic Days | Total number of days with upper respiratory symptoms during the 90 day intervention. Symptoms are measured using the Franklin Immune Scale, which measures the severity of 50 symptoms. Scores range from 0 (symptom not present) to 5 (symptom is severe), with higher scores indicating greater severity. | 13 weeks |
| Incidence of Upper Respiratory Events | Total number of upper respiratory events during the 90 day intervention. An event is classified as a series of continuous days with upper respiratory symptoms. | 13 weeks |
| Duration of Upper Respiratory Events | Total number of days per upper respiratory event. An event is classified as a series of continuous days with upper respiratory symptoms. | 13 weeks |
| Symptom Severity | Average daily symptom score on the Franklin Immune Scale which measures the severity of 50 symptoms. Scores range from 0 (symptom not present) to 5 (symptom is severe), with higher scores indicating greater severity. | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of COVID-19 | Total number of COVID-19 diagnoses during the 90 day period, as confirmed through an at-home laboratory verified diagnostic test. | 13 weeks |
| Duration of COVID-19 | Total number of days per COVID-19 infection. An event is classified as a series of continuous days with COVID-19 symptoms and the receipt of a positive COVID-19 test. |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive Health | The Franklin Digestive Health Scale measures gastrointestinal health across 4 domains, with higher scores indicating greater gastrointestinal health. | baseline and 13 weeks |
| Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin Health Research Center | Recruiting | Franklin | Tennessee | 37067 | United States |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| C000713810 | elderberry extract |
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| Placebo | Other | Inactive placebo |
|
| 13 weeks |
| Severity of COVID-19 | Average daily symptom score on the Franklin Immune Scale which measures the severity of 50 symptoms. Scores range from 0 (symptom not present) to 5 (symptom is severe), with higher scores indicating greater severity. | 13 weeks |
| Incidence of influenza | Total number of influenza diagnoses during the 90 day period, as confirmed through an in-office diagnostic test. | 13 weeks |
| Duration of influenza | Total number of days per influenza infection. An event is classified as a series of continuous days with flu-like symptoms and the receipt of a positive influenza test. | 13 weeks |
| Severity of influenza | Average daily symptom score on the Franklin Immune Scale which measures the severity of 50 symptoms. Scores range from 0 (symptom not present) to 5 (symptom is severe), with higher scores indicating greater severity. | 13 weeks |
| Energy Levels | The Franklin Energy Scale measures energy levels across 7 domains, with higher scores indicating greater energy levels. This produces a total energy score, as well as 7 subscores. | baseline and 13 weeks |
| Sleep Quality | The Franklin Sleep Scale measures energy levels across 10 domains, with higher scores indicating greater sleep quality. | baseline and 13 weeks |
| Cognitive Wellbeing | The Franklin Cognitive Health Scale measures brain health across 7 domains, with higher scores indicating greater cognitive well-being. | baseline and 13 weeks |
| Stress Levels | The Franklin Stress Scale measures stress levels across 7 domains, with higher scores indicating greater stress management. | baseline and 13 weeks |
Total number of adverse events during the 13 week intervention
| 13 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D009976 | Orthomyxoviridae Infections |
| D010850 | Picornaviridae Infections |