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

NCT02814617 | Completed Phase 2 DMC

• 1 other identifier: CBG-PI-CME
• Study Type: interventional
• Target: 80
• 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-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α).

Conditions

Immunity

Outcome Measures

Primary Outcomes (1)

• Changes in serum natural killer cell activity

  Baseline, 8 weeks

Secondary Outcomes (1)

• Changes in Cytokine(IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α)

  Baseline, 8 weeks

Study Arms (2)

Cordyceps sinensis mycelium culture extract

EXPERIMENTAL

Cordyceps sinensis mycelium culture extract 1.68 g

Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.68 g

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Cordyceps sinensis mycelium culture extract 1.68 g DIETARY_SUPPLEMENT

Cordyceps sinensis mycelium culture extract 1.68 g

Cordyceps sinensis mycelium culture extract

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 20-75 years old
• Able to give informed consent

You may not qualify if:

• 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.

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

Related Publications (1)

• Jung SJ, Jung ES, Choi EK, Sin HS, Ha KC, Chae SW. Immunomodulatory effects of a mycelium extract of Cordyceps (Paecilomyces hepiali; CBG-CS-2): a randomized and double-blind clinical trial. BMC Complement Altern Med. 2019 Mar 29;19(1):77. doi: 10.1186/s12906-019-2483-y.

  PMID: 30925876 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: June 14, 2016
• First Posted: June 28, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

KR (1)