Clinical trial NCT05435144: Elderberry for Immune Support
Official title: The Effects of Supplementation With ElderCraft® Elderberry Extract: A Randomized, Triple-blind, Placebo Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Respiratory Tract Infection
COVID-19
Flu
Flu Like Illness
Cold
Keywords: elderberry
anthocyanins
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
Collaborators: name: Artemis International
name: IPRONA
First posted: 2022-06-28
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Upper Respiratory Symptomatic Days
timeFrame: 13 weeks
measure: Incidence of Upper Respiratory Events
timeFrame: 13 weeks
measure: Duration of Upper Respiratory Events
timeFrame: 13 weeks
measure: Symptom Severity
timeFrame: 13 weeks
Secondary outcomes:
measure: Incidence of COVID-19
timeFrame: 13 weeks
measure: Duration of COVID-19
timeFrame: 13 weeks
measure: Severity of COVID-19
timeFrame: 13 weeks
measure: Incidence of influenza
timeFrame: 13 weeks
measure: Duration of influenza
timeFrame: 13 weeks
measure: Severity of influenza
timeFrame: 13 weeks
measure: Energy Levels
timeFrame: baseline and 13 weeks
measure: Sleep Quality
timeFrame: baseline and 13 weeks
measure: Cognitive Wellbeing
timeFrame: baseline and 13 weeks
measure: Stress Levels
timeFrame: baseline and 13 weeks
Other outcomes:
measure: Digestive Health
timeFrame: baseline and 13 weeks
measure: Adverse Events
timeFrame: 13 weeks
Locations:
city: Franklin
country: United States
facility: Franklin Health Research Center
state: Tennessee
Study officials:
References: