A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia
Efficacy and Safety of Aged Garlic Powder on Lipids
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 26, 2011
CompletedResults Posted
Study results publicly available
October 4, 2012
CompletedOctober 12, 2012
October 1, 2012
8 months
July 21, 2011
July 26, 2012
October 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)
12 weeks
Changes in Triglycerides
12 weeks
Changes in Total Cholesterol
12 weeks
Changes in Apo-A1(Apolipoprotein A1)
12 weeks
Changes in Apo-B(Apolipoprotein B)
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Aged garlic powder
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mild hypercholesterolemic subjects aged from 20 to 80 years
- had no received lipid-lowering drugs for at least 3 months prior to the recruitment
You may not qualify if:
- self-reported pregnancy,lactation
- prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Dal-Sik Kim
- Organization
- Clinical trial center for Functional Food in Chonbuk Nat'l University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Dal-Sik Kim, MD
Chonbuk National University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 26, 2011
Study Start
July 1, 2010
Primary Completion
March 1, 2011
Study Completion
July 1, 2011
Last Updated
October 12, 2012
Results First Posted
October 4, 2012
Record last verified: 2012-10