The Effects of Supplementation With ElderCraft® Elderberry Extract: A Randomized, Triple-blind, Placebo Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Incidence of Upper Respiratory Symptomatic Days
研究概览
简要总结
The purpose of this study is to confirm and quantify the effects of ElderCraft® elderberry extract on immune health.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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.
结局指标
主要结局
Incidence of Upper Respiratory Symptomatic Days
时间窗: 13 weeks
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.
Incidence of Upper Respiratory Events
时间窗: 13 weeks
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.
Duration of Upper Respiratory Events
时间窗: 13 weeks
Total number of days per upper respiratory event. An event is classified as a series of continuous days with upper respiratory symptoms.
Symptom Severity
时间窗: 13 weeks
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.
次要结局
- Duration of COVID-19(13 weeks)
- Incidence of COVID-19(13 weeks)
- Severity of COVID-19(13 weeks)
- Incidence of influenza(13 weeks)
- Duration of influenza(13 weeks)
- Severity of influenza(13 weeks)
- Energy Levels(baseline and 13 weeks)
- Sleep Quality(baseline and 13 weeks)
- Cognitive Wellbeing(baseline and 13 weeks)
- Stress Levels(baseline and 13 weeks)