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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05435144
Other study ID # 22-07-2400
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 26, 2022
Est. completion date June 30, 2023

Study information

Verified date October 2022
Source Franklin Health Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 420
Est. completion date June 30, 2023
Est. primary completion date March 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Elderberry
European black elderberry extract
Other:
Placebo
Inactive placebo

Locations

Country Name City State
United States Franklin Health Research Center Franklin Tennessee

Sponsors (3)

Lead Sponsor Collaborator
Franklin Health Research Artemis International, IPRONA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Digestive Health The Franklin Digestive Health Scale measures gastrointestinal health across 4 domains, with higher scores indicating greater gastrointestinal health. baseline and 13 weeks
Other Adverse Events Total number of adverse events during the 13 week intervention 13 weeks
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Incidence of influenza Total number of influenza diagnoses during the 90 day period, as confirmed through an in-office diagnostic test. 13 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary Sleep Quality The Franklin Sleep Scale measures energy levels across 10 domains, with higher scores indicating greater sleep quality. baseline and 13 weeks
Secondary 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
Secondary Stress Levels The Franklin Stress Scale measures stress levels across 7 domains, with higher scores indicating greater stress management. baseline and 13 weeks
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