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Elderberry for Immune Support

Primary Purpose

Upper Respiratory Tract Infection, COVID-19, Flu

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elderberry
Placebo
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Tract Infection focused on measuring elderberry, anthocyanins

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Franklin Health Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Arm

Placebo Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
Incidence of influenza
Total number of influenza diagnoses during the 90 day period, as confirmed through an in-office diagnostic test.
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.
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.
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.
Sleep Quality
The Franklin Sleep Scale measures energy levels across 10 domains, with higher scores indicating greater sleep quality.
Cognitive Wellbeing
The Franklin Cognitive Health Scale measures brain health across 7 domains, with higher scores indicating greater cognitive well-being.
Stress Levels
The Franklin Stress Scale measures stress levels across 7 domains, with higher scores indicating greater stress management.

Full Information

First Posted
June 22, 2022
Last Updated
October 10, 2022
Sponsor
Franklin Health Research
Collaborators
Artemis International, IPRONA
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1. Study Identification

Unique Protocol Identification Number
NCT05435144
Brief Title
Elderberry for Immune Support
Official Title
The Effects of Supplementation With ElderCraft® Elderberry Extract: A Randomized, Triple-blind, Placebo Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
March 28, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research
Collaborators
Artemis International, IPRONA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection, COVID-19, Flu, Flu Like Illness, Cold
Keywords
elderberry, anthocyanins

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Elderberry
Other Intervention Name(s)
ElderCraft, Sambucus nigra
Intervention Description
European black elderberry extract
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive placebo
Primary Outcome Measure Information:
Title
Incidence of Upper Respiratory Symptomatic Days
Description
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
Title
Incidence of Upper Respiratory Events
Description
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
Title
Duration of Upper Respiratory Events
Description
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
Title
Symptom Severity
Description
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
Secondary Outcome Measure Information:
Title
Incidence of COVID-19
Description
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
Title
Duration of COVID-19
Description
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
Title
Severity of COVID-19
Description
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
Title
Incidence of influenza
Description
Total number of influenza diagnoses during the 90 day period, as confirmed through an in-office diagnostic test.
Time Frame
13 weeks
Title
Duration of influenza
Description
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
Title
Severity of influenza
Description
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
Title
Energy Levels
Description
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
Title
Sleep Quality
Description
The Franklin Sleep Scale measures energy levels across 10 domains, with higher scores indicating greater sleep quality.
Time Frame
baseline and 13 weeks
Title
Cognitive Wellbeing
Description
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
Title
Stress Levels
Description
The Franklin Stress Scale measures stress levels across 7 domains, with higher scores indicating greater stress management.
Time Frame
baseline and 13 weeks
Other Pre-specified Outcome Measures:
Title
Digestive Health
Description
The Franklin Digestive Health Scale measures gastrointestinal health across 4 domains, with higher scores indicating greater gastrointestinal health.
Time Frame
baseline and 13 weeks
Title
Adverse Events
Description
Total number of adverse events during the 13 week intervention
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Franklin Health Research Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessie Hawkins, PhD
Phone
615-642-1919
Email
j.hawkins@franklinhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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