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Completed

NCT Number: NCT01811511

Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic syndrome. The investigators measured decrement of body fat parameters, including Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their blood pressure.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Obesity Research Center of Chonbuk National University

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 18-29 years old
  • BMI(body mass index) ≥ 23 kg/m2 or WC(Waist Circumference) ≥ 90(men), WC(Waist Circumference) ≥ 85(women)
  • Able to give informed consent

Exclusion criteria

  • Allergic or hypersensitive to any of the ingredients in the test products
  • The diagnosis of type 1 and type 2 diabetes or fasting glucose ≥ 126mg/dL
  • Systolic pressure ≥ 160mmHg, diastolic pressure ≥ 100mmHg
  • 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

Treatment and study plan

Chungkookjang

Dietary Supplement

Other names: Chungkookjang(35g/day)

Placebo

Dietary Supplement

Other names: Placebo(35g/day)

Primary outcomes

  1. Change in Body Fat Mass

    Time frame: 12 weeks

    Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in Percent Body Fat

    Time frame: 12 weeks

    Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).

Secondary outcomes

  1. Change in Glucose

    Time frame: 12 weeks

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

  2. Changes in Cholesterol

    Time frame: 12 weeks

    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
2013
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2013
Registry last updated
Feb 10, 2015

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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