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Completed

NCT Number: NCT01865370

Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

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 19-55 years old
  • Total Cholesterol 200~260 mg/dl or LDL-C 110~190 mg/dl
  • Able to give informed consent

Exclusion criteria

  • Allergic or hypersensitive to any of the ingredients in the test products
  • 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

Kochujang Pills

Dietary Supplement

Kochujang Pills (34.5g/day)

Placebo

Dietary Supplement

Placebo (34.5g/day)

Primary outcomes

  1. Changes in Total Cholesterol

    Time frame: 12 weeks

    Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)

    Time frame: 12 weeks

    LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Secondary outcomes

  1. Changes in Triglyceride

    Time frame: 12 weeks

    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in HDL-C(High Density Lipoprotein-cholesterol)

    Time frame: 12 weeks

    HDL-C(High Density Lipoprotein-cholesterol) 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
2011
Primary completion
2012
Study completion
2012
First posted
May 30, 2013
Registry last updated
May 30, 2013

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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