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Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

C

Chonbuk National University

Status

Completed

Conditions

Immunity

Treatments

Dietary Supplement: Cauliflower Mushroom extract
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01736787
HANABIO-PI-CM

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Cauliflower Mushroom extract
Experimental group
Treatment:
Dietary Supplement: Cauliflower Mushroom extract
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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