Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014