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

NCT04144673 | Completed

• 1 other identifier: 19SIHN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Immune Support; Active lifestyle; Silver; Healthy Adults; Cold; WURSS

Outcome Measures

Primary Outcomes (1)

• The difference between Bio-Active Silver Hydrosol™ and placebo in the mean global severity index, as measured by area under the curve (AUC) for the WURSS-24 daily symptom scores after 60 days supplementation.

  The Wisconsin Upper Respiratory Symptom Survey (WURSS) is a questionnaire used to evaluate the negative impact of acute URTIs. The WURSS-24 contains 24 items scored on a Likert-type severity scale. It contains the same items as the WURSS-21 along with headache, body ache, and fever to capture influenza-like illness symptoms. The items are scored on a 0 (do not have this symptom) to 7 (severe) scale.

  60 days

Study Arms (2)

Investigational Product

EXPERIMENTAL

Other: Silver Hydrosol

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Silver Hydrosol OTHER

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

Also known as: Sovereign Silver, Bio-Active Silver Hydrosol™

Investigational Product

Placebo OTHER

Placebo water with no active ingredients

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natural Immunogenics Corp.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 19674476 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel study

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: November 14, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)