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Elderberry for Immune Support | Clinical Trials | Clareo Health

UNKNOWNNA

Elderberry for Immune Support

The Effects of Supplementation With ElderCraft® Elderberry Extract: A Randomized, Triple-blind, Placebo Controlled Clinical Trial.

NCT05435144•Nutraceuticals Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (1)

Franklin Health Research Center

Franklin, Tennessee, United States

Key Dates

Start Date

August 26, 2022

Primary Completion Date

March 28, 2023

Completion Date

June 30, 2023

Last Updated

October 12, 2022

Enrollment

420

ESTIMATED participants

Conditions

Upper Respiratory Tract InfectionCOVID-19FluFlu Like IllnessCold

Interventions

Elderberry

DIETARY_SUPPLEMENT

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Elderberry for Immune Support

Inclusion Criteria

Exclusion Criteria

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