Recruiting

Elderberry

Sponsor:

Nutraceuticals Research Institute

Code:

NCT05435144

Conditions

Upper Respiratory Tract Infection

COVID-19

Flu

Flu Like Illness

Cold

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

Interventions

Elderberry

Placebo

Study Details

Brief summary:

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

Conditions

Upper Respiratory Tract Infection

COVID-19

Flu

Flu Like Illness

Cold

Study ID

NCT05435144

Start date

Aug 26, 2022

Status verified date

Oct, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Mar 28, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

Elderberry

European black elderberry extract

Placebo

Inactive placebo

Primary outcome measure

  • Incidence of Upper Respiratory Symptomatic Days [ Time Frame: 13 weeks ]
  • Incidence of Upper Respiratory Events [ Time Frame: 13 weeks ]
  • Duration of Upper Respiratory Events [ Time Frame: 13 weeks ]
  • Symptom Severity [ Time Frame: 13 weeks ]

Central Contacts and Locations

Locations

Franklin Health Research Center

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Jessie Hawkins, PhD

615-642-1919j.hawkins@franklinhealth.org

More Information

Sponsor

Nutraceuticals Research Institute

Last update posted

Oct 12, 2022

Last verified

Oct, 2022

Keywords

  • elderberry
  • anthocyanins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nutraceuticals Research Institute on 2022-10-12.