Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

Immunity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736787
• Other study ID #: HANABIO-PI-CM
• Status: Completed
• Phase: N/A
• Start date: September 17, 2012
• Est. completion date: January 18, 2013

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 18, 2013
• Est. primary completion date: January 18, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immunity

Intervention

Dietary Supplement:
• Cauliflower Mushroom extract
Cauliflower Mushroom extract (1g/day)
• Placebo
Placebo (1g/day)

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cytotoxicity	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	12 weeks
Primary	Changes in Cytokine (IL-4, IL-10, IFN- ?, TNF-a)	Cytokine (IL-4, IL-10, IFN- ?, TNF-a) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Secondary	Changes in CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT)	CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks