HyperlipidemiaPhase 2/3NCT01402102
A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia
A Phase 2/3 study testing Aged garlic powder in people with Hyperlipidemia, run by Chonbuk National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Aged garlic powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild hypercholesterolemic subjects aged from 20 to 80 years
- had no received lipid-lowering drugs for at least 3 months prior to the recruitment
Who cannot join
- self-reported pregnancy,lactation
- prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
Official title: Efficacy and Safety of Aged Garlic Powder on Lipids
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Aged garlic powder, Placebo powder
- Keywords
- Aged garlic, Hyperlipidemic, LDL, HDL, Triglyceride
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged garlic powderDietary supplement
Aged garlic powder(6.0g/day)
Placebo powderDietary supplement
Placebo powder(6.0g/day)
| Study group | Role | What they receive |
|---|---|---|
| Aged garlic powder | Experimental | Not described Receives: Dietary Supplement: Aged garlic powder |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (6)
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).
Measured: 12 weeks
Changes in Triglycerides
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in Apo-A1(Apolipoprotein A1)
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in Apo-B(Apolipoprotein B)
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in FFA(Free Fatty Acid)
FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
- Investigators
- Dal-Sik Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402102
- Sponsor's protocol ID
- Doul-BGarlic-001
- Status last verified
- Oct 2012
- First submitted
- 21 Jul 2011
- Last updated
- 12 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aged Garlic Powder on Lipids
- ClinicalTrials.gov ID
- NCT01402102
- Acronym / sponsor ID
- Doul-BGarlic-001
- Conditions
- Hyperlipidemia
- Keywords
- Aged garlic, Hyperlipidemic, LDL, HDL, Triglyceride
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Posted 4 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aged garlic powder | Experimental | Dietary Supplement: Aged garlic powder |
| Placebo | Placebo comparator | Dietary Supplement: Placebo powder |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild hypercholesterolemic subjects aged from 20 to 80 years
- had no received lipid-lowering drugs for at least 3 months prior to the recruitment
Key exclusion criteria (2 listed)
- self-reported pregnancy,lactation
- prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aged garlic powderAged garlic powder(6.0g/day) | Dietary supplement | Aged garlic powder |
| Placebo powderPlacebo powder(6.0g/day) | Dietary supplement | Placebo |
Primary outcome
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).
6 secondary outcomes
Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)
Time frame: 12 weeks
Changes in Triglycerides
Time frame: 12 weeks
Changes in Total Cholesterol
Time frame: 12 weeks
Changes in Apo-A1(Apolipoprotein A1)
Time frame: 12 weeks
Changes in Apo-B(Apolipoprotein B)
Time frame: 12 weeks
Changes in FFA(Free Fatty Acid)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dal-Sik Kim, MD principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aged garlic powder in people with Hyperlipidemia, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.