Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

Not Applicable

Completed

• Conditions: Immunity
• Interventions: Dietary Supplement: Cauliflower Mushroom extract; Dietary Supplement: Placebo

• Registration Number: NCT01736787
• Lead Sponsor: Chonbuk National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-17
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Primary Completion: 2013-01-18
• Study Completion: 2013-01-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cauliflower Mushroom extract	Cauliflower Mushroom extract	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in Cytotoxicity	12 weeks	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)	12 weeks	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

Name	Time	Method
Changes in CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT)	12 weeks	CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT) was measured in study visit 1(0 week) and visit 3(12 week).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of