A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia

Phase 2

Completed

• Conditions: Hyperlipidemia
• Interventions: Dietary Supplement: Aged garlic powder; Dietary Supplement: Placebo powder

• Registration Number: NCT01402102
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects who were given aged garlic powder over a period of 12 weeks. We measured serum lipids, including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood pressure.

Detailed Description

An increased serum cholesterol level is an important risk factor for the development of cardiovascular and cerebrovascular disease. Reduction of these and other risk factors through dietary modification, behavioral changes, and medicinal intervention has already substantially decreased the incidence and mortality from cardiovascular and cerebrovascular disease. Supplementation of the diet with certain biofactors may further reduce such risk factors. Aged garlic belongs to a group of dietary supplements that may lessen the incidence of cardiovascular and cerebrovascular disease by reducing lipids levels and decreasing platelet responsiveness to activating agents.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Results First Submitted: 2012-07-26
• Results First Submitted QC: 2012-09-05
• Status Verified: 2012-10
• Results First Posted: 2012-10-04
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Mild hypercholesterolemic subjects aged from 20 to 80 years
• had no received lipid-lowering drugs for at least 3 months prior to the recruitment

Exclusion Criteria

• self-reported pregnancy,lactation
• prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aged garlic powder	Aged garlic powder	-
Placebo	Placebo powder	-

Primary Outcome Measures

Name	Time	Method
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)	12 weeks	LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures

Name	Time	Method
Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)	12 weeks	HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Triglycerides	12 weeks	Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Total Cholesterol	12 weeks	Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Apo-A1(Apolipoprotein A1)	12 weeks	Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Apo-B(Apolipoprotein B)	12 weeks	Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in FFA(Free Fatty Acid)	12 weeks	FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of