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

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ClinicalTrials.gov Identifier: NCT02244372
Recruitment Status : Unknown
Verified September 2014 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Description
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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)

Condition or disease Intervention/treatment Phase
Immunity Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g Dietary Supplement: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cordyceps sinensis mycelium culture extract 0.76 g
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
Cordyceps sinensis mycelium culture extract 1.15 g
 Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g
Placebo Comparator: Placebo
Placebo
 Dietary Supplement: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Cytotoxicity [ Time Frame: 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 Outcome Measures :
  1. Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α) [ Time Frame: 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).

  2. Changes in hs-CRP [ Time Frame: 4, 8 weeks ]
    hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week).


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244372


Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Eun-Soo Jung, MS    82-63-250-2423    esjung@jbctc.org   
Sponsors and Collaborators
Chonbuk National University Hospital
More Information
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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT02244372     History of Changes
Other Study ID Numbers: CHE-PI-CM
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2)
immunity