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Completed

NCT Number: NCT01402102

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aged garlic powder

Dietary Supplement

Aged garlic powder(6.0g/day)

Placebo Powder

Dietary Supplement

Placebo powder(6.0g/day)

Primary outcomes

  1. Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)

    Time frame: 12 weeks

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

  2. Changes in Triglycerides

    Time frame: 12 weeks

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

  3. Changes in Total Cholesterol

    Time frame: 12 weeks

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

  4. Changes in Apo-A1(Apolipoprotein A1)

    Time frame: 12 weeks

    Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).

  5. Changes in Apo-B(Apolipoprotein B)

    Time frame: 12 weeks

    Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).

  6. Changes in FFA(Free Fatty Acid)

    Time frame: 12 weeks

    FFA(free fatty acid) 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

Official study title

Efficacy and Safety of Aged Garlic Powder on Lipids

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2011
Registry last updated
Oct 12, 2012

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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