Elderberry for Immune Support

Study Overview
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Brief Summary
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The purpose of this study is to confirm and quantify the effects of ElderCraft® elderberry extract on immune health.

Detailed Description
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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.

Official Title
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The Effects of Supplementation With ElderCraft® Elderberry Extract: A Randomized, Triple-blind, Placebo Controlled Clinical Trial.

Conditions
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Flu, Upper Respiratory Tract Infection, COVID-19, Flu Like Illness, Cold

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness and demonstrated ability to comply with all study procedures and availability for the duration of the study Aged 20-65 Lives in the United States within driving distance of the research center In good general health as evidenced by medical history BMI <31 Ability to take oral supplements and willing to commit to taking 2 capsules a day for 3 months For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the intervention period Employed full time in an occupation with direct and prolonged exposure to the public (i.e. teacher, healthcare provider, etc) or regularly engaged in high exposure activities. Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: Current use of the following pharmaceuticals: immunosuppressants Pregnancy, trying to conceive or breastfeeding Organ transplant recipient Known allergic reactions to elderberries Positive COVID-19 test within 180 days of the study period COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study Receipt of 4+ COVID-19 vaccines Current diagnosis or lifetime history of an autoimmune condition (including but not limited to Lupus, Addisons, Graves, Hypothyroidism, Multiple Sclerosis, or Type 1 Diabetes) OR cancer OR chronic kidney disease OR chronic liver disease OR chronic lung disease (i.e. COPD, pulmonary embolism) OR cystic fibrosis OR severe heart disease (i.e. heart failure, coronary artery disease, cardiomyopathy) OR HIV infection OR immunocompromised status OR sickle cell disease OR tuberculosis Recent dramatic weight changes (10% change in body weight in the last 6 months) Existing usage of a polyphenol-based supplement, including but not limited to elderberry, cranberry, bilberry, quercetin, or resveratrol. Existing usage of an immune supporting supplement such as echinacea, probiotics, elderberry, or any other dietary supplements marketed as immune support. Routine dietary consumption of high levels of polyphenols or anthocyanins as determined by dietary intake questionnaire.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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. | Dietary Supplement: Elderberry<br>* European black elderberry extract<br>* Other names: Sambucus nigra;|
| Placebo Comparator: Placebo Arm<br>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. | Other: Placebo<br>* Inactive placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthocyanins, elderberry