Upper Respiratory Tract InfectionNCT05435144
Elderberry for Immune Support
A study testing Elderberry in people with Upper Respiratory Tract Infection and COVID-19, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to confirm and quantify the effects of ElderCraft® elderberry extract on immune health. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection, COVID-19, Flu
- What is being tested?
- Elderberry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Franklin Health Research Center
Franklin, Tennessee, 37067
Jessie Hawkins, PhD, 615-642-1919, j.hawkins@franklinhealth.org
About this study
Official title: The Effects of Supplementation With ElderCraft® Elderberry Extract: A Randomized, Triple-blind, Placebo Controlled Clinical Trial.
The purpose of this study is to confirm and quantify the effects of ElderCraft® elderberry extract on immune health.
Read the 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.
- Conditions
- Upper Respiratory Tract Infection, COVID-19, Flu, Flu Like Illness, Cold
- Being tested
- Elderberry, Placebo
- Keywords
- elderberry, anthocyanins
- Medical subject headings
- Respiratory Tract Infections, COVID-19, Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElderberryDietary supplement
Also called ElderCraft, Sambucus nigra
European black elderberry extract
PlaceboOther
Inactive placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Dietary Supplement: Elderberry |
| Placebo Arm | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 13 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 13 weeks
Incidence of influenza
Total number of influenza diagnoses during the 90 day period, as confirmed through an in-office diagnostic test.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 13 weeks
Sleep Quality
The Franklin Sleep Scale measures energy levels across 10 domains, with higher scores indicating greater sleep quality.
Measured: 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.
Measured: baseline and 13 weeks
Stress Levels
The Franklin Stress Scale measures stress levels across 7 domains, with higher scores indicating greater stress management.
Measured: baseline and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start26 Aug 2022
- Primary completion28 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Artemis International, IPRONA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435144
- Sponsor's protocol ID
- 22-07-2400
- Status last verified
- Oct 2022
- First submitted
- 22 Jun 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Supplementation With ElderCraft® Elderberry Extract: A Randomized, Triple-blind, Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05435144
- Acronym / sponsor ID
- 22-07-2400
- Conditions
- Upper Respiratory Tract Infection, COVID-19, Flu, Flu Like Illness, Cold
- Keywords
- elderberry, anthocyanins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Collaborators
- Artemis International, IPRONA
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 28 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Dietary Supplement: ElderberryParticipants 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. |
| Placebo Arm | Placebo comparator | Other: PlaceboParticipants will receive a 13-week supply of inert placebo capsules matched for polysaccharide content. Participants will take a total of two capsules each day. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElderberryAlso: ElderCraft, Sambucus nigraEuropean black elderberry extract | Dietary supplement | Intervention Arm |
| PlaceboInactive placebo | Other | Placebo Arm |
Primary outcome
Incidence of Upper Respiratory Symptomatic Days
Time frame: 13 weeks
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
Time frame: 13 weeks
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
Time frame: 13 weeks
Total number of days per upper respiratory event. An event is classified as a series of continuous days with upper respiratory symptoms.
Symptom Severity
Time frame: 13 weeks
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.
10 secondary outcomes
Incidence of COVID-19
Time frame: 13 weeks
Duration of COVID-19
Time frame: 13 weeks
Severity of COVID-19
Time frame: 13 weeks
Incidence of influenza
Time frame: 13 weeks
Duration of influenza
Time frame: 13 weeks
Severity of influenza
Time frame: 13 weeks
Energy Levels
Time frame: baseline and 13 weeks
Sleep Quality
Time frame: baseline and 13 weeks
Cognitive Wellbeing
Time frame: baseline and 13 weeks
Stress Levels
Time frame: baseline and 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elderberry in people with Upper Respiratory Tract Infection and COVID-19, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Upper Respiratory Symptomatic Days (time frame: 13 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.