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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
420
European black elderberry extract
Inactive placebo
Franklin Health Research Center
Franklin, Tennessee, United States
RECRUITINGIncidence 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 13 weeks
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.
Time frame: 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.
Time frame: 13 weeks
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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.
Time frame: 13 weeks
Incidence of influenza
Total number of influenza diagnoses during the 90 day period, as confirmed through an in-office diagnostic test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 13 weeks
Sleep Quality
The Franklin Sleep Scale measures energy levels across 10 domains, with higher scores indicating greater sleep quality.
Time frame: 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.
Time frame: baseline and 13 weeks
Stress Levels
The Franklin Stress Scale measures stress levels across 7 domains, with higher scores indicating greater stress management.
Time frame: baseline and 13 weeks