Status:
UNKNOWN
Elderberry for Immune Support
Lead Sponsor:
Nutraceuticals Research Institute
Collaborating Sponsors:
Artemis International
IPRONA
Conditions:
Upper Respiratory Tract Infection
COVID-19
Eligibility:
All Genders
20-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT05435144
Start Date
August 26 2022
End Date
June 30 2023
Last Update
October 12 2022
Active Locations (1)
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1
Franklin Health Research Center
Franklin, Tennessee, United States, 37067