Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity

Study Overview
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Brief Summary
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The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP, antibody titer, and upper respiratory tract infection(URI)

Official Title
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A 8-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity

Conditions
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Immunity

Intervention / Treatment
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* Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g
* Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 20-80 years old Who had suffered more than twice Upper respiratory infection* disorder or common cold causing URI Able to give informed consent Exclusion Criteria: WBC concentration below 3000 ㎕ Subjects vaccinated against influenza within the last 6 months prior to the study Subjects with Upper respiratory infection at screening visit Subjects with BMI < 18.5 kg/m2 at screening visit Allergic or hypersensitive to any of the ingredients in the test products Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cordyceps sinensis mycelium culture extract 0.76 g<br>Cordyceps sinensis mycelium culture extract 0.76 g | Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g<br> <br> |
| Experimental: Cordyceps sinensis mycelium culture extract 1.15 g<br>Cordyceps sinensis mycelium culture extract 1.15 g | Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cytotoxicity | Cytotoxicity was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week). cytotoxicity was measured by NK cell activity. Cytotoxicity (%) = (experimental release - spontaneous release) / (maximum release - spontaneous release) x 100 | 4, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α) | Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α) was measured in study visit 1(0 week), visit 2(4 week), and visit 3(8 week). | 4, 8 weeks | 
| Changes in hs-CRP | hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week). | 4, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2), immunity