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Completed

NCT Number: NCT01736787

Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

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.

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Key information

Conditions

Immunity

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cauliflower Mushroom extract

Dietary Supplement

Cauliflower Mushroom extract (1g/day)

Placebo

Dietary Supplement

Placebo (1g/day)

Primary outcomes

  1. Changes in Cytotoxicity

    Time frame: 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

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

    Time frame: 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 outcomes

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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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