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

NCT ID: NCT04144673

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-14
• Study Completion Date: 2020-06-01

Brief Summary

The objective of this study is to investigate the ability of Bio-Active Silver Hydrosol™ in providing immune support in healthy adult males and females participating in intense aerobic exercise. Sixty eligible participants are planned to be randomized into either the investigational product or treatments arms and will consume the study product for 60 days (check-in visit on day 28). Questionnaires will be completed and blood and saliva samples will be collected to measure the endpoints.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational Product

Group Type: EXPERIMENTAL

Silver Hydrosol

Intervention Type: OTHER

Silver quantity will be 7 doses per day, with 50 mcg per dose.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo water with no active ingredients

Interventions

Silver Hydrosol

Silver quantity will be 7 doses per day, with 50 mcg per dose.

Intervention Type: OTHER

Placebo

Placebo water with no active ingredients

Intervention Type: OTHER

Other Intervention Names

Sovereign Silver, Bio-Active Silver Hydrosol™

Eligibility Criteria

Inclusion Criteria

1. Provided voluntary, written, informed consent to participate in the study

2. Females and males between 19 and 65 years of age inclusive

3. 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,

1. 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:

2. 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)

3. Double-barrier method

4. Intrauterine devices

5. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)

6. Vasectomy of partner at least 6 months prior to screening

4. BMI between 18.5 to 29.9 kg/m2 inclusive

5. 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

6. Agrees to provide a verbal history of flu vaccination

7. Healthy as determined by laboratory results, medical history, and physical exam or as determined by the QI

8. Agrees to maintain current diet and exercise programs

9. Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits

Exclusion Criteria

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial

2. Subject has a known allergy to the test material's active or inactive ingredients

3. Verbal confirmation of a diagnosed chronic inflammatory condition

4. Verbal confirmation of the diagnosis of any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis)

5. Chronic consumption of oral anti-inflammatory medications such as cyclosporine for skin conditions such as psoriasis, dermatitis, rosacea

6. 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)

7. Verbal confirmation of chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis

8. Verbal confirmation of active shingles and/or herpes virus infections, within 2 months of baseline

9. Use of medical marijuana including THC-free CBD (any form of consumption)

10. 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

11. Use of immunomodulators (including corticosteroids) such as immunosuppressant or immune-stimulant medications within 4 weeks of baseline

12. Taking antibiotics within 2 weeks of screening

13. Use of immune support supplements unless willing to undergo washout

14. Use of multivitamins unless on a stable regimen for 3 months as assessed by QI

15. Verbal confirmation of Type I or Type II diabetes or clinically important hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder

16. History or current diagnosis of renal disease with the exception of a history of kidney stones symptom-free for 1 year

17. 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

18. 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

19. 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.

20. Verbal confirmation of the diagnosis of Hepatitis B/C positive

21. Chronic unusual sleep routine (examples: irregular routine with frequent late nights, studying, partying)

22. Use of Prebiotics and Probiotics unless on a stable regimen for 3 months as assessed by QI.

23. Smoking study participants must be willing to abstain from tobacco use in the morning of a clinical visit

24. 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)

25. Alcohol or drug abuse in the past year

26. Blood donation during or within 30 days of the last study visit

27. Subjects with unstable medical conditions as assessed by the QI

28. Clinically significant abnormal laboratory results at screening as assessed by the QI

29. Participation in a clinical research trial within 30 days prior to randomization

30. Individuals who are cognitively impaired and/or who are unable to give informed consent

31. 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Natural Immunogenics Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

References

Barrett B, Brown RL, Mundt MP, Thomas GR, Barlow SK, Highstrom AD, Bahrainian M. Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Health Qual Life Outcomes. 2009 Aug 12;7:76. doi: 10.1186/1477-7525-7-76.

Reference Type: BACKGROUND

PMID: 19674476 (View on PubMed)

Related Links

https://www.fammed.wisc.edu/wurss/

Explains the development of the WURSS-24 from the WURSS-21

Other Identifiers

19SIHN

Identifier Type: -

Identifier Source: org_study_id