Elderberry for Immune Support

NCT05435144 | Unknown

• 1 other identifier: 22-07-2400
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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

Keywords

elderberry; anthocyanins

Outcome Measures

Primary Outcomes (4)

• Incidence of Upper Respiratory Symptomatic Days

  Total number of days with upper respiratory symptoms during the 90 day intervention. Symptoms are measured using the Franklin Immune Scale, which measures the severity of 50 symptoms. Scores range from 0 (symptom not present) to 5 (symptom is severe), with higher scores indicating greater severity.

  13 weeks

• Incidence of Upper Respiratory Events

  Total number of upper respiratory events during the 90 day intervention. An event is classified as a series of continuous days with upper respiratory symptoms.

  13 weeks

• Duration of Upper Respiratory Events

  Total number of days per upper respiratory event. An event is classified as a series of continuous days with upper respiratory symptoms.

  13 weeks

• Symptom Severity

  Average daily symptom score on the Franklin Immune Scale which measures the severity of 50 symptoms. Scores range from 0 (symptom not present) to 5 (symptom is severe), with higher scores indicating greater severity.

  13 weeks

Secondary Outcomes (10)

• Incidence of COVID-19

  13 weeks

• Duration of COVID-19

  13 weeks

• Severity of COVID-19

  13 weeks

• Incidence of influenza

  13 weeks

• Duration of influenza

  13 weeks

Other Outcomes (2)

• Digestive Health

  baseline and 13 weeks

• Adverse Events

  13 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Dietary Supplement: Elderberry

Placebo Arm

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Elderberry DIETARY_SUPPLEMENT

European black elderberry extract

Also known as: ElderCraft, Sambucus nigra

Intervention Arm

Placebo OTHER

Inactive placebo

Placebo Arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead
• Artemis International: collaborator
• IPRONA: collaborator

Study Sites (1)

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; COVID-19; Influenza, Human; Common Cold

Interventions

elderberry extract

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Orthomyxoviridae Infections; Picornaviridae Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: August 26, 2022
• Primary Completion: March 28, 2023
• Study Completion: June 30, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)