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

NCT02244372 | Completed DMC

• 1 other identifier: CHE-PI-CM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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)

Conditions

Immunity

Keywords

Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2); immunity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α)

  4, 8 weeks

• Changes in hs-CRP

  4, 8 weeks

Study Arms (3)

Cordyceps sinensis mycelium culture extract 0.76 g

EXPERIMENTAL

Cordyceps sinensis mycelium culture extract 0.76 g

Dietary Supplement: Cordyceps sinensis mycelium culture extract 0.76 g

Cordyceps sinensis mycelium culture extract 1.15 g

EXPERIMENTAL

Cordyceps sinensis mycelium culture extract 1.15 g

Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.15 g

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Cordyceps sinensis mycelium culture extract 0.76 g DIETARY_SUPPLEMENT

Cordyceps sinensis mycelium culture extract 0.76 g

Cordyceps sinensis mycelium culture extract 1.15 g DIETARY_SUPPLEMENT

Cordyceps sinensis mycelium culture extract 1.15 g

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

KR (1)