Elderberry for Immune Support

NCT ID: NCT05435144

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-26
• Study Completion Date: 2023-06-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Elderberry

Intervention Type: DIETARY_SUPPLEMENT

European black elderberry extract

Placebo Arm

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Inactive placebo

Interventions

Elderberry

European black elderberry extract

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Inactive placebo

Intervention Type: OTHER

Other Intervention Names

ElderCraft; Sambucus nigra

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Artemis International

UNKNOWN

Sponsor Role: collaborator

IPRONA

UNKNOWN

Sponsor Role: collaborator

Nutraceuticals Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Franklin Health Research Center

Franklin, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jessie Hawkins, PhD

Role: primary

j.hawkins@franklinhealth.org

615-642-1919

Other Identifiers

22-07-2400

Identifier Type: -

Identifier Source: org_study_id