ISRCTN15838713已完成未知
A triple-blind placebo-controlled parallel study on healthy volunteers to evaluate the immune protection of 2 dietary supplements in a 56 day period pre and post flu vaccination at 28 days.
nigen Inc.0 个研究点目标入组 75 人开始时间: 2021年9月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37168053/ results (added 15/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females between 40 and 80 years of age, inclusive
- •2. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening, or,
- •Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •3. Participants who have not yet but willing to receive the influenza vaccine
- •4. Agrees to provide a verbal history of flu vaccination
- •5. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements
- •6. Healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)
- •7. Willingness to complete questionnaires and diaries associated with the study and to complete all clinic visits
- •8. Provided voluntary, written, informed consent to participate in the study
排除标准
- •1. Women who are pregnant, breast feeding, or planning to become pregnant during the study
- •2. Participant has a known allergy to the active or inactive ingredients in UP360, UP446, placebo, or QIV
- •3. Self-reported diagnosis of COVID-19 prior to baseline
- •4. Unvaccinated participants with self-reported flu prior to baseline
- •5. Current use of prescribed immunomodulators (including corticosteroids) such as immunosuppressants or immunostimulants within 4 weeks of baseline
- •6. Current use of dietary supplement or herbal medicines associated with boosting or modulating the immune system.
- •7. Current use of specific prescribed cardiac medication or over-the-counter medication or supplements that may aggravate electrolyte imbalance as assessed by QI
- •8. Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
- •9. Individuals who are unable to give informed consent
- •10. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
研究者
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