Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids

NCT01735149 | Unknown Phase 2 DMC

• 1 other identifier: SRCM-HL-KOCHUJANG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Changes in Total Cholesterol

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

  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).

  12 weeks

Secondary Outcomes (2)

• Changes in Triglyceride

  12 weeks

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

  12 weeks

Study Arms (2)

Kochujang Pills

EXPERIMENTAL

Dietary Supplement: Kochujang Pills

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Kochujang Pills DIETARY_SUPPLEMENT

Kochujang Pills (34.5g/day)

Kochujang Pills

Placebo DIETARY_SUPPLEMENT

Placebo (34.5g/day)

Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2013
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

KR (1)