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

November 20, 2012
November 26, 2012
September 2012
September 2012   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01736787 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity
Not Provided

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Immunity
  • Dietary Supplement: Cauliflower Mushroom extract
    Cauliflower Mushroom extract (1g/day)
  • Dietary Supplement: Placebo
    Placebo (1g/day)
  • Experimental: Cauliflower Mushroom extract
    Intervention: Dietary Supplement: Cauliflower Mushroom extract
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
30 Years to 65 Years
Yes
Korea, Republic of
 
NCT01736787
HANABIO-PI-CM
Yes
Soo-Wan Chae, Chonbuk National University Hospital
Chonbuk National University Hospital
Not Provided
Not Provided
Chonbuk National University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP