HyperlipidemiaNCT00255216
Policosanol for the Treatment of Hypercholesterolemia
A study of Hyperlipidemia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Aug 2005
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Males, or females who are not pregnant and have a highly reliable contraception method (i.e. hormonal or surgical contraception)
- Baseline LDL-C between 130 and 200
Who cannot join
- History of Coronary Artery Disease - Patients will be excluded if they have been told at any time that they have heart disease based on a history of abnormal EKG, stress test, or coronary catheterization.
- History of Cerebrovascular Disease - Patients with a history of stroke or TIA will be excluded from the study.
- History of Congestive Heart Disease - Patients will be excluded if they have a history of congestive heart failure, regardless of the underlying cause or stage of disease. This will be true even if patients do not have a history of coronary artery disease.
- History of Diabetes - Patients will be asked if they have ever been diagnosed with any type of diabetes in the past. All patients with diabetes including type I, type II, and gestational diabetes will be excluded.
- History of Renal Impairment - Any patient with a history of kidney problems including transient renal impairment or current renal insufficiency will be excluded.
- History of Uncontrolled Hypertension - If patients report a history of poorly controlled blood pressure, defined as systolic blood pressure consistently over 140 or diastolic blood pressure consistently greater than 90, they will be excluded. Blood pressure will be checked at the beginning of the study and patients will be excluded if the initial reading reveals a systolic blood pressure over 160 and/or a diastolic blood pressure over 100.
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- History of Untreated or Clinically Evident Thyroid Disease - Patients will be excluded if they report a history of untreated thyroid disease or current symptoms of an untreated thyroid disorder.
- Currently taking medications or supplements with known or potential lipid-altering effects including: phytosterols, statins, cholestin, niacin, fibrates, psyllium fiber, bile acid sequestrants, diabetic medications, and weight control medications such as orlistat
- Currently having residual side effects from a previously discontinued lipid medication
- Pregnancy or breastfeeding
- Triglycerides > 300 at baseline
- Patients with clinical atherosclerotic disease which would be considered a coronary heart disease risk equivalent per ATP III guidelines - including carotid artery disease, peripheral arterial disease, and abdominal aortic aneurysm.
- Patients with 2 or more cardiac risk factors and over 20% risk of coronary disease according to their 10- year Framingham risk assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Cardiovascular Health
Charlotte, North Carolina, 28207
About this study
Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba.
This study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.
Read more
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH).
Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.
Read the detailed description
Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Policosanol has been used in Cuba since 1991 to treat high cholesterol. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba. According to the Cuban data, policosanol can lower total cholesterol, lower low-density lipoprotein cholesterol (LDL-C), and raise high-density lipoprotein cholesterol (HDL-C). Based on post-marketing surveys, this drug appears to be devoid of any biochemical, hematological, or clinical adverse effects.
Confirmation of this data on policosanol by scientifically rigorous experiments and trials in this country would provide a safe and effective therapeutic option for the treatment of hypercholesterolemia. Consequently, policosanol has the potential to become a valuable tool in the fight against coronary heart disease - a major cause of mortality in the United States.
This pilot study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH). Future studies could include an assessment of the effects of policosanol on other markers for coronary heart disease and potential use in combination with current lipid medications. The overall goal is to perform a large multi-center clinical outcome trial to establish the precise clinical benefits of policosanol.
Summary: Demonstration of the lipid-lowering ability of policosanol is an initial step in providing a safe, cost-effective therapy for hypercholesterolemia, thereby advancing the treatment and prevention of cardiovascular disease in this country.
Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.
Hypotheses: After 8 weeks of therapy policosanol 40 mg/day will:
- Produce a statistically significant reduction in LDL-C compared to placebo.
- Provide a statistically significant reduction in LDL particle number and C-reactive protein.
- Conditions
- Hyperlipidemia
- Being tested
- Policosanol supplement (oral capsule) vs. placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Policosanol supplement (oral capsule) vs. placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Variables:
Percent change in LDL-C between baseline and 8 weeks in the policosanol and placebo arms.
Secondary outcomes (7)
Secondary Outcome Variables:
Percent change between baseline and 8 weeks in both study arms for the following parameters:
• total cholesterol, HDL-C, and triglycerides
• hs-CRP
• LDL Particle concentration
• ALT
• Adverse effects profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2005 (estimated)
- Study startJan 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael F Dulin, MD PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255216
- Sponsor's protocol ID
- Poli-01
- Status last verified
- Oct 2005
- First submitted
- 16 Nov 2005
- Last updated
- 30 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Policosanol for the Treatment of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00255216
- Acronym / sponsor ID
- Poli-01
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Aug 2005
- First posted
- 18 Nov 2005 (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.
Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba.
This study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH).
Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.
Detailed description
Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Policosanol has been used in Cuba since 1991 to treat high cholesterol. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba. According to the Cuban data, policosanol can lower total cholesterol, lower low-density lipoprotein cholesterol (LDL-C), and raise high-density lipoprotein cholesterol (HDL-C). Based on post-marketing surveys, this drug appears to be devoid of any biochemical, hematological, or clinical adverse effects.
Confirmation of this data on policosanol by scientifically rigorous experiments and trials in this country would provide a safe and effective therapeutic option for the treatment of hypercholesterolemia. Consequently, policosanol has the potential to become a valuable tool in the fight against coronary heart disease - a major cause of mortality in the United States.
This pilot study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH). Future studies could include an assessment of the effects of policosanol on other markers for coronary heart disease and potential use in combination with current lipid medications. The overall goal is to perform a large multi-center clinical outcome trial to establish the precise clinical benefits of policosanol.
Summary: Demonstration of the lipid-lowering ability of policosanol is an initial step in providing a safe, cost-effective therapy for hypercholesterolemia, thereby advancing the treatment and prevention of cardiovascular disease in this country.
Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.
Hypotheses: After 8 weeks of therapy policosanol 40 mg/day will:
- Produce a statistically significant reduction in LDL-C compared to placebo.
- Provide a statistically significant reduction in LDL particle number and C-reactive protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Males, or females who are not pregnant and have a highly reliable contraception method (i.e. hormonal or surgical contraception)
- Baseline LDL-C between 130 and 200
Key exclusion criteria (13 listed)
- History of Coronary Artery Disease - Patients will be excluded if they have been told at any time that they have heart disease based on a history of abnormal EKG, stress test, or coronary catheterization.
- History of Cerebrovascular Disease - Patients with a history of stroke or TIA will be excluded from the study.
- History of Congestive Heart Disease - Patients will be excluded if they have a history of congestive heart failure, regardless of the underlying cause or stage of disease. This will be true even if patients do not have a history of coronary artery disease.
- History of Diabetes - Patients will be asked if they have ever been diagnosed with any type of diabetes in the past. All patients with diabetes including type I, type II, and gestational diabetes will be excluded.
- History of Renal Impairment - Any patient with a history of kidney problems including transient renal impairment or current renal insufficiency will be excluded.
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 |
|---|---|---|
| Policosanol supplement (oral capsule) vs. placebo | Drug | – |
Primary outcome
Primary Outcome Variables:
Percent change in LDL-C between baseline and 8 weeks in the policosanol and placebo arms.
7 secondary outcomes
Secondary Outcome Variables:
Percent change between baseline and 8 weeks in both study arms for the following parameters:
• total cholesterol, HDL-C, and triglycerides
• hs-CRP
• LDL Particle concentration
• ALT
• Adverse effects profile
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 30 Mar 2023.
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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.
Michael F Dulin, MD PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hyperlipidemia, run by Wake Forest University Health Sciences 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 3 inclusion and 13 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 30 Mar 2023. 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.
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?
Primary Outcome Variables:. The study lists 2 primary outcomes in all. 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 30 Mar 2023.