Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

NCT01736787 | Completed DMC

• 1 other identifier: HANABIO-PI-CM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunity

Keywords

Cauliflower Mushroom extract; immunity

Outcome Measures

Primary Outcomes (2)

• 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

• Changes in Cytokine (IL-4, IL-10, IFN- γ, TNF-α)

  Cytokine (IL-4, IL-10, IFN- γ, TNF-α) was measured in study visit 1(0 week) and visit 3(12 week).

  12 weeks

Secondary Outcomes (1)

• Changes in CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT)

  12 weeks

Study Arms (2)

Cauliflower Mushroom extract

EXPERIMENTAL

Dietary Supplement: Cauliflower Mushroom extract

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Cauliflower Mushroom extract DIETARY_SUPPLEMENT

Cauliflower Mushroom extract (1g/day)

Cauliflower Mushroom extract

Placebo DIETARY_SUPPLEMENT

Placebo (1g/day)

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 29, 2012
• Study Start: September 17, 2012
• Primary Completion: January 18, 2013
• Study Completion: January 18, 2013
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

KR (1)