Elderberry for Immune Support

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435144
• Other study ID #: 22-07-2400
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cold
• COVID-19
• Flu
• Flu Like Illness
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

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