Elderberry for Immune Support

Last updated: October 10, 2022
Sponsor: Franklin Health Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Rhinitis

Influenza

Bronchitis (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05435144
22-07-2400
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

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

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.

Connect with a study center

  • Franklin Health Research Center

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

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