Immunity
Conditions
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-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α).
Interventions
DIETARY_SUPPLEMENTCordyceps sinensis mycelium culture extract 1.68 g
Cordyceps sinensis mycelium culture extract 1.68 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 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females 20-75 years old * Able to give informed consent
Exclusion criteria
* WBC concentration below 3000 ㎕, over 8000㎕ * 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 |
|---|---|
| Changes in serum natural killer cell activity | Baseline, 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Cytokine(IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α) | Baseline, 8 weeks |
Countries
South Korea
Outcome results
None listed