Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

This study is currently recruiting participants.
Verified November 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01736787
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT), and monitored their blood pressure.


Condition Intervention Phase
Immunity
Dietary Supplement: Cauliflower Mushroom extract
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in Cytotoxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Cytotoxicity was measured in study visit 1(0 week) and visit 3(12 week). cytotoxicity was measured by NK cell activity. Cytotoxicity (%) = (experimental release - spontaneous release) / (maximum release - spontaneous release) x 100

  • Changes in Cytokine (IL-4, IL-10, IFN- γ, TNF-α) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Cytokine (IL-4, IL-10, IFN- γ, TNF-α) was measured in study visit 1(0 week) and visit 3(12 week).


Secondary Outcome Measures:
  • Changes in CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT) was measured in study visit 1(0 week) and visit 3(12 week).


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cauliflower Mushroom extract Dietary Supplement: Cauliflower Mushroom extract
Cauliflower Mushroom extract (1g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (1g/day)

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females 30-65 years old
  • Weight within ±30% of ideal body weight
  • Able to give informed consent

Exclusion Criteria:

  • WBC concentration below 3000 ㎕
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736787

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Heon-Gu Lee, MD    82-63-270-3069    leeh-k@jbnu.ac.kr   
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01736787     History of Changes
Other Study ID Numbers: HANABIO-PI-CM
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Cauliflower Mushroom extract
immunity

ClinicalTrials.gov processed this record on April 15, 2014