Immunity
Conditions
Keywords
Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2), immunity
Brief summary
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)
Interventions
DIETARY_SUPPLEMENTCordyceps sinensis mycelium culture extract 0.76 g
DIETARY_SUPPLEMENTCordyceps sinensis mycelium culture extract 1.15 g
DIETARY_SUPPLEMENTPlacebo
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cytotoxicity | 4, 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hs-CRP | 4, 8 weeks | hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week). |
| Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α) | 4, 8 weeks | 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). |
Countries
South Korea
Outcome results
None listed