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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Hydrosol | Other | Silver quantity will be 7 doses per day, with 50 mcg per dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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,
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:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A 5R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19674476 | Background | 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. |
| Label | URL |
|---|---|
| Explains the development of the WURSS-24 from the WURSS-21 | View source |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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Randomized, double-blind, placebo-controlled, parallel study
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| Placebo | Other | Placebo water with no active ingredients |
|
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |