A Study Investigating the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support

Inclusion criteria

• Provided voluntary, written, informed consent to participate in the study
• Females and males between 19 and 65 years of age inclusive
• 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) or have been post-menopausal (natural or surgically) 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
• BMI between 18.5 to 29.9 kg/m2 inclusive
• Individuals participating in an intense aerobic sport (e.g. cycling, running, triathlon, swimming, soccer, Nordic skiing, basketball, hockey, gym etc.) for greater than or equal to 5 hours a week
• Agrees to provide a verbal history of flu vaccination
• Healthy as determined by laboratory results, medical history, and physical exam or as determined by the QI
• Agrees to maintain current diet and exercise programs
• Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits

Exclusion criteria

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Subject has a known allergy to the test material's active or inactive ingredients
• Verbal confirmation of a diagnosed chronic inflammatory condition
• Verbal confirmation of the diagnosis of any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis)
• Chronic consumption of oral anti-inflammatory medications such as cyclosporine for skin conditions such as psoriasis, dermatitis, rosacea
• Chronic consumption of anti-inflammatory medications or medications known to affect immune function on a daily basis, including medications for allergies and asthma with the exception of Ventolin, within 4 weeks of baseline visit (visit 2)
• Verbal confirmation of chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis
• Verbal confirmation of active shingles and/or herpes virus infections, within 2 months of baseline
• Use of medical marijuana including THC-free CBD (any form of consumption)
• Use of recreational marijuana (any form of consumption) within the past 4 weeks and is unwilling to stop use for the duration of the study
• Use of immunomodulators (including corticosteroids) such as immunosuppressant or immune-stimulant medications within 4 weeks of baseline
• Taking antibiotics within 2 weeks of screening
• Use of immune support supplements unless willing to undergo washout
• Use of multivitamins unless on a stable regimen for 3 months as assessed by QI
• Verbal confirmation of Type I or Type II diabetes or clinically important hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder
• History or current diagnosis of renal disease with the exception of a history of kidney stones symptom-free for 1 year
• Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Current or pre-existing thyroid condition. Treatment on a stable dose medication for 6 months will be reviewed on a case-by-case basis by the QI
• History of or current blood/bleeding disorders with the exception of a history of anemia caused by a deficiency of a mineral or vitamin, and no longer present.
• Verbal confirmation of the diagnosis of Hepatitis B/C positive
• Chronic unusual sleep routine (examples: irregular routine with frequent late nights, studying, partying)
• Use of Prebiotics and Probiotics unless on a stable regimen for 3 months as assessed by QI.
• Smoking study participants must be willing to abstain from tobacco use in the morning of a clinical visit
• High alcohol intake (average >2 standard drinks per day, or ≥15 standard drinks per week for men, or ≥8 standard drinks per week for women)
• Alcohol or drug abuse in the past year
• Blood donation during or within 30 days of the last study visit
• Subjects with unstable medical conditions as assessed by the QI
• Clinically significant abnormal laboratory results at screening as assessed by the QI
• Participation in a clinical research trial within 30 days prior to randomization
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Any other condition which in the QI's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose a significant risk to the subject