Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01736787

Enrollment

Registered

2012-11-29

Start date

2012-09-17

Completion date

2013-01-18

Last updated

2019-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunity

Keywords

Cauliflower Mushroom extract, immunity

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.

Interventions

DIETARY_SUPPLEMENTCauliflower Mushroom extract

Cauliflower Mushroom extract (1g/day)

DIETARY_SUPPLEMENTPlacebo

Placebo (1g/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026