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

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

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)

Study Overview

• Status: Completed
• Conditions: Immunity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Cordyceps sinensis mycelium culture extract 0.76 g; Dietary supplement: Cordyceps sinensis mycelium culture extract 1.15 g

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo
Experimental: Cordyceps sinensis mycelium culture extract 0.76 g	Dietary supplement: Cordyceps sinensis mycelium culture extract 0.76 g
Experimental: Cordyceps sinensis mycelium culture extract 1.15 g	Dietary supplement: Cordyceps sinensis mycelium culture extract 1.15 g

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: immunity; Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2)
• Other Study ID Numbers: CHE-PI-CM