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

Chonbuk National University Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Hyperlipidemia

Interventions

Kochujang PillsDIETARY_SUPPLEMENT

Kochujang Pills (34.5g/day)

PlaceboDIETARY_SUPPLEMENT

Placebo (34.5g/day)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

Changes in Total Cholesterol

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

Time frame: 12 weeks

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

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

Time frame: 12 weeks

Secondary Outcomes

Changes in Triglyceride

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

Time frame: 12 weeks

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

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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