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

Phase 2

Completed

• Conditions: Immunity
• Interventions: Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.68 g; Dietary Supplement: Placebo

• Registration Number: NCT02814617
• Lead Sponsor: Chonbuk National University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Status Verified: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-23
• Last Update Submitted: 2016-06-23
• Study First Posted: 2016-06-28
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cordyceps sinensis mycelium culture extract	Cordyceps sinensis mycelium culture extract 1.68 g	Cordyceps sinensis mycelium culture extract 1.68 g
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Changes in serum natural killer cell activity	Baseline, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in Cytokine(IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α)	Baseline, 8 weeks

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of