Last updated: October 10, 2022
Sponsor: Franklin Health Research
Overall Status: Active - Recruiting
Phase
N/A
Condition
Acute Rhinitis
Influenza
Bronchitis (Pediatric)
Treatment
N/AClinical Study ID
NCT05435144
22-07-2400
Ages 20-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness and demonstrated ability to comply with all study procedures andavailability 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 atleast 1 month prior to screening and agreement to use such a method during studyparticipation 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 exposureactivities.
- Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion
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 priorto the start of the study
- Receipt of 4+ COVID-19 vaccines
- Current diagnosis or lifetime history of an autoimmune condition (including but notlimited to Lupus, Addisons, Graves, Hypothyroidism, Multiple Sclerosis, or Type 1Diabetes) OR cancer OR chronic kidney disease OR chronic liver disease OR chronic lungdisease (i.e. COPD, pulmonary embolism) OR cystic fibrosis OR severe heart disease (i.e. heart failure, coronary artery disease, cardiomyopathy) OR HIV infection ORimmunocompromised 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 toelderberry, 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 asdetermined by dietary intake questionnaire.
Study Design
Total Participants: 420
Study Start date:
August 26, 2022
Estimated Completion Date:
June 30, 2023
Study Description
Connect with a study center
Franklin Health Research Center
Franklin, Tennessee 37067
United StatesActive - Recruiting
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