HypercholesterolemiaPhase 2/3NCT00056511
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
A Phase 2/3 study testing Fresh garlic or garlic supplements in people with Hypercholesterolemia, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether fresh garlic can positively affect cholesterol in adults with moderately high cholesterol levels. This study will also determine whether the same effects can be found for two main types of garlic supplements: a dried powdered garlic (designed to yield the same effect… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Fresh garlic or garlic supplements
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Apr 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL-C 130-190 mg/dL (fasting single sample)
- BMI (body mass index) 19-30 kg/m2 (42-66 lb/m2)
- Weight stable for last 2 months
- Not actively on a weight loss plan
- Ethnicity representative of local population
- No plans to move from the area over the next 9 months
Who cannot join
- Pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next year
- Diabetes (type I or II) or history of gestational diabetes
- Heart disease
- Active neoplasms
- Renal or liver disease
- Hyperthyroidism or hypothyroidism
Show all 10Show fewer
- Lipid lowering medications (known to affect lipid metabolism, platelet function, or antioxidant status)
- Blood pressure medications
- Excessive alcohol intake (self reported, more than 3 drinks/day)
- Currently under psychiatric care or severely clinically depressed
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Center for Research in Disease Prevention
Palo Alto, California, 94304-1583
About this study
Official title: Comparing Effects of 3 Sources of Garlic on Serum Lipids
The purpose of this study is to determine whether fresh garlic can positively affect cholesterol in adults with moderately high cholesterol levels. This study will also determine whether the same effects can be found for two main types of garlic supplements: a dried powdered garlic (designed to yield the same effect as fresh garlic) and an aged garlic extract preparation.
Read the detailed description
Garlic supplements are the most consumed herbal products in the United States. The most common health claim made for garlic supplements is cholesterol lowering activity. This claim has not been supported by recent clinical trials and meta-analyses. However, data suggest that it is not necessarily the garlic that has been ineffective, but rather the particular garlic preparations being used. To date, the predominant type of garlic preparation used in these clinical trials has been dried garlic powders. A few clinical trials have reported beneficial lipid effects using an aged garlic extract, and only a small number of inconclusive uncontrolled trials have used fresh garlic. A rigorous trial directly comparing different types of garlic preparations for their effects on serum lipids is needed.
Adults with moderately elevated low density lipoprotein cholesterol (LDL-C) will be randomized to one of four groups for 6 months: fresh garlic, dried powdered garlic tablets, aged garlic extract tablets, or placebo control. The fresh garlic will be provided to patients with "study sandwiches"; all other groups will receive the same study sandwiches without the garlic. All patients will take daily study tablets, but the tablet assignment will be double-blind. Patients will pick up study sandwiches twice a week and study tablets once every 2 weeks for 28 weeks. Blood samples will be taken once a month, with additional blood draws at the start and end of the study.
- Conditions
- Hypercholesterolemia
- Being tested
- Fresh garlic or garlic supplements
- Keywords
- Garlic, Supplements, Adults, Hypercholesterolemics, Randomized Clinical Trial
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh garlic or garlic supplementsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol; measured at baseline, once a month, and post-intervention
Secondary outcomes (4)
HDL-cholesterol; measured at baseline, once a month, and post-intervention
Triacylglycerols; measured at baseline, once a month, and post-intervention
Blood pressure; measured at baseline, once a month, and post-intervention
Platelet aggregation; measured at baseline, once a month, and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2003 (estimated)
- Study startMay 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Investigators
- Christopher D. Gardner, Ph.D., Principal investigator, Stanford Center for Research in Disease Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056511
- Sponsor's protocol ID
- R01AT001108-01
- Status last verified
- Aug 2006
- First submitted
- 14 Mar 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Gardner CD, Lawson LD, Block E, Chatterjee LM, Kiazand A, Balise RR, Kraemer HC. Effect of raw garlic vs commercial garlic supplements on plasma lipid concentrations in adults with moderate hypercholesterolemia: a randomized clinical trial. Arch Intern Med. 2007 Feb 26;167(4):346-53. doi: 10.1001/archinte.167.4.346.
PubMed 17325296
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effects of 3 Sources of Garlic on Serum Lipids
- ClinicalTrials.gov ID
- NCT00056511
- Acronym / sponsor ID
- R01AT001108-01
- Conditions
- Hypercholesterolemia
- Keywords
- Garlic, Supplements, Adults, Hypercholesterolemics, Randomized Clinical Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Study start
- May 2002
- Study completion
- Apr 2005
- First posted
- 18 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether fresh garlic can positively affect cholesterol in adults with moderately high cholesterol levels. This study will also determine whether the same effects can be found for two main types of garlic supplements: a dried powdered garlic (designed to yield the same effect as fresh garlic) and an aged garlic extract preparation.
Detailed description
Garlic supplements are the most consumed herbal products in the United States. The most common health claim made for garlic supplements is cholesterol lowering activity. This claim has not been supported by recent clinical trials and meta-analyses. However, data suggest that it is not necessarily the garlic that has been ineffective, but rather the particular garlic preparations being used. To date, the predominant type of garlic preparation used in these clinical trials has been dried garlic powders. A few clinical trials have reported beneficial lipid effects using an aged garlic extract, and only a small number of inconclusive uncontrolled trials have used fresh garlic. A rigorous trial directly comparing different types of garlic preparations for their effects on serum lipids is needed.
Adults with moderately elevated low density lipoprotein cholesterol (LDL-C) will be randomized to one of four groups for 6 months: fresh garlic, dried powdered garlic tablets, aged garlic extract tablets, or placebo control. The fresh garlic will be provided to patients with "study sandwiches"; all other groups will receive the same study sandwiches without the garlic. All patients will take daily study tablets, but the tablet assignment will be double-blind. Patients will pick up study sandwiches twice a week and study tablets once every 2 weeks for 28 weeks. Blood samples will be taken once a month, with additional blood draws at the start and end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- LDL-C 130-190 mg/dL (fasting single sample)
- BMI (body mass index) 19-30 kg/m2 (42-66 lb/m2)
- Weight stable for last 2 months
- Not actively on a weight loss plan
- Ethnicity representative of local population
Key exclusion criteria (10 listed)
- Pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next year
- Diabetes (type I or II) or history of gestational diabetes
- Heart disease
- Active neoplasms
- Renal or liver disease
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 |
|---|---|---|
| Fresh garlic or garlic supplements | Drug | – |
Primary outcome
LDL-cholesterol; measured at baseline, once a month, and post-intervention
4 secondary outcomes
HDL-cholesterol; measured at baseline, once a month, and post-intervention
Triacylglycerols; measured at baseline, once a month, and post-intervention
Blood pressure; measured at baseline, once a month, and post-intervention
Platelet aggregation; measured at baseline, once a month, and post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
- Derived from this study: PubMed 17325296Gardner CD, Lawson LD, Block E, Chatterjee LM, Kiazand A, Balise RR, Kraemer HC. Effect of raw garlic vs commercial garlic supplements on plasma lipid concentrations in adults with moderate hypercholesterolemia: a randomized clinical trial. Arch Intern Med. 2007 Feb 26;167(4):346-53. doi: 10.1001/archinte.167.4.346.
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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.
Christopher D. Gardner, Ph.D. principal investigator
Stanford Center for Research in Disease Prevention
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 Fresh garlic or garlic supplements in people with Hypercholesterolemia, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 6 inclusion and 10 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 18 Aug 2006. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LDL-cholesterol; measured at baseline, once a month, and post-intervention. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056511, which also lists 1 linked publication.
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 18 Aug 2006.