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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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Upper respiratory tract infections cause cold and flu-like symptoms and are the most common form of acute illness. Certain populations are at increased risk of upper respiratory tract infections including athletes who train at a high level of intensity for prolonged periods of time. Consequently, some athletes experience higher rates of cold and flu-like symptoms than the general population.
Euglena gracilis is a micro-algae which can synthesize many nutrients necessary for human health, including insoluble beta glucan. Thus, intake of whole cell Euglena may be beneficial to athletes by providing essential vitamins to optimize immune function.
At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and be given the opportunity to seek more information if needed, or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening visit will proceed.
Screening assessments include:
Eligible participants will return to the clinic for baseline assessments. Baseline (day 0) assessments include:
At the end-of-study visit (Day 90) participants will return to the clinic for Visit 3 assessments with unused investigational product, completed study diaries, daily symptom questionnaires, daily gastrointestinal and bowel diaries.
Visit 3 assessments include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Treatment | Experimental | Whole Cell Euglena delivering βeta Glucan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Cell Euglena containing Beta Glucan | Dietary Supplement | Whole Cell Euglena containing >50% Beta Glucan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of upper respiratory tract infections | incidence of very mild/mild/ moderate/ severe upper respiratory tract infection symptoms | ANOVA of 90 day supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Duration | Duration of very mild/mild/moderate/sever upper respiratory tract infection symptoms | 30 and 90 days |
| Stress | Effect of treatment on Stress via Perceived Stress Scale Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A 5R8 | Canada |
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Randomized, Double-Blind, Placebo Controlled
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All parties, except an outside person not involved in the study, will be blinded to the treatment conditions
| Placebo | Dietary Supplement | microcrystalline cellulose, hypromellose, titanium dioxide, water |
|
| 90 days |
| Secretory IgA | Effect of treatment on secretory IgA levels | 90 days |
| Natural Killer (NK) Cell Population | Effect of treatment on NK cell population changes | 90 days |
| Gastrointestinal status | Effect of treatment on gastrointestinal status via questionnaire | 30 and 90 days |