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

Hyperlipidemia Clinical Trial

Official title:

Efficacy and Safety of Aged Garlic Powder on Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402102
• Other study ID #: Doul-BGarlic-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 21, 2011
• Last updated: October 11, 2012
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2012
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Aged garlic powder
Aged garlic powder(6.0g/day)
• Placebo powder
Placebo powder(6.0g/day)

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)	LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)	HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in Triglycerides	Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in Total Cholesterol	Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in Apo-A1(Apolipoprotein A1)	Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in Apo-B(Apolipoprotein B)	Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in FFA(Free Fatty Acid)	FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes