A clinical trial to investigate two products on supporting immune function in healthy adults
- Conditions
- Prevention of flu and flu like symptomsInfections and Infestations
- Registration Number
- ISRCTN15838713
- Lead Sponsor
- nigen Inc.
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37168053/ results (added 15/05/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in the increase in immune parameters as assessed by lymphocyte populations (CD3+, CD4+, CD8+,CD25+) and immunoglobulins (IgG, IgM, and IgA) in blood between UP360, UP446 and placebo at Day 28 and 56
- Secondary Outcome Measures
Name Time Method