Metabolic SyndromeNCT00518960
The Effects of ProAlgaZyme on HDL Cholesterol in Individuals With Metabolic Syndrome
A study testing ProAlgaZyme in people with Metabolic Syndrome and Hyperlipidemia, run by Health Enhancement Products, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of ProAlgaZyme in increasing levels of HDL 'good' cholesterol and decreasing total cholesterol and C-reactive protein in patients with Metabolic Syndrome. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Hyperlipidemia
- What is being tested?
- ProAlgaZyme
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2007
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index 28-40
- Subjects with at least 3 of the following parameters:
- Elevated waist circumference: Men - Equal to or greater than 40 in (102cm); Women - Equal to or greater than 35 in (88cm)
- Elevated triglycerides: Equal to or greater than 150 mg/dL
- Reduced HDL ("good") cholesterol: Men - Less than 40 mg/dL; Women - Less than 50 mg/dL
- Elevated blood pressure: Equal to or greater than 130/85 mmHg
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- Elevated fasting glucose: Equal to or greater than 100 mg/dL
- Elevated CRP: Equal to or greater than 5 mg/L
- Subjects with ability to comprehend and complete the questionnaires and forms
- Subjects whose schedules permit 4 visits to the study center over the duration of the trial
- Subjects who are likely to comply with study procedures and test article consumption
- Subjects who are likely to abstain from taking unauthorized supplements/medications or participating in any other clinical trial or experimental treatment during this trial
Who cannot join
- Subjects with uncontrolled hypertension as defined as greater than 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been maintained)
- Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control
- Subjects with a history of hepatic or renal disease, insulin dependent diabetes, active cancer, HIV infection or blood dyscrasias
- Current use of lipid-lowering medications, anti-inflammatories such as low-dose aspirin, or herbal therapies known to affect inflammation or blood lipids 8 weeks prior to study entry
- Current use of Metformin
- More than moderate alcohol use (> 14 drinks per week)
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- Use of illicit drugs
- Acute coronary syndrome, heart failure, CVA, or coronary intervention within 6 months prior to study
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
MAPS Applied Research Center (MARC)
Edina, Minnesota, 55435
About this study
Official title: The Effects of ProAlgaZyme Novel Algae Infusion on HDL Cholesterol and C-Reactive Protein in Individuals With Metabolic Syndrome
The purpose of this study is to determine the effectiveness of ProAlgaZyme in increasing levels of HDL 'good' cholesterol and decreasing total cholesterol and C-reactive protein in patients with Metabolic Syndrome.
Read the detailed description
Cardiovascular disease (CVD) is the most common cause of mortality in the United States. In 1988, Reaven, et al. published findings that indicate a majority of individuals who developed CVD had multiple concurrent risk factors including dyslipidemia, hypertension, and hyperglycemia. Reaven, et al., defined this cluster of risk factors as Syndrome X and hypothesized that insulin resistance was the underlying factor in its development. Over time, metabolic syndrome has been used as a more meaningful term and additional risk factors have been associated with its diagnosis (Grundy, et al. 2004). Metabolic syndrome is an increasingly prevalent problem in the United States and other westernized nations. It is estimated that approximately 50 million Americans have metabolic syndrome. The risk factors linked to metabolic syndrome include:
- Abdominal obesity
- Atherogenic dyslipidemia (high triglycerides, low HDL cholesterol and high LDL cholesterol)
- Elevated blood pressure
- Insulin resistance with or without glucose intolerance
- Pro-thrombotic state (e.g., high fibrinogen or plasminogen activator inhibitor-1 in the blood)
- Pro-inflammatory state [e.g. elevated C-reactive protein (CRP)in the blood]
The management goals for metabolic syndrome include reducing the risk for developing CVD and type 2 diabetes. Therefore, therapy is directed at reducing LDL cholesterol, blood pressure and glucose as well as increasing HDL cholesterol levels. Additional interventions to control blood pressure and lipids provide the next line of treatment for patients with metabolic syndrome.
ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, will be evaluated in this trial for its effects on circulating lipids. According to the sponsor, ProAlgaZyme is expected to increase the circulating levels of HDL cholesterol while lowering total cholesterol and CRP. ProAlgaZyme was previously tested in a double blind, placebo controlled, pilot trial in 60 subjects with metabolic syndrome (30 subjects per arm), conducted at the University of Yaoundé, Cameroon. Statistically significant (p < 0.05 or better) improvements were seen in total cholesterol, HDL-C and C-reactive protein when compared to placebo. (In Press - Lipids in Health and Disease)
The present study will evaluate the effect of ProAlgaZyme versus placebo on blood lipids and hsCRP in subjects who meet the criteria for Metabolic Syndrome.
- Conditions
- Metabolic Syndrome, Hyperlipidemia
- Being tested
- ProAlgaZyme
- Keywords
- ProAlgaZyme, Algae, High density lipoprotein; HDL, C-Reactive Protein; CRP, Hyperlipidemia, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProAlgaZymeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL Cholesterol
Measured: 12 weeks
Secondary outcomes (3)
Lipid Panel (Total Chol., LDL-Chol., Triglycerides, Total Chol./HDL-Chol. ratio)
Measured: 12 weeks
C-Reactive Protein
Measured: 12 weeks
Blood Pressure
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 posted21 Aug 2007 (estimated)
- Study startApr 2007
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Enhancement Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MAPS Applied Research Center
- Investigators
- Terence Pertile, Ph.D., Principal investigator, MAPS Applied Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518960
- Sponsor's protocol ID
- H-0003-02
- Other IDs
- MARC007-003
- Status last verified
- Aug 2007
- First submitted
- 17 Aug 2007
- Last updated
- 21 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of ProAlgaZyme Novel Algae Infusion on HDL Cholesterol and C-Reactive Protein in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00518960
- Acronym / sponsor ID
- H-0003-02
- Conditions
- Metabolic Syndrome, Hyperlipidemia
- Keywords
- ProAlgaZyme, Algae, High density lipoprotein; HDL, C-Reactive Protein; CRP, Hyperlipidemia, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Health Enhancement Products, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MAPS Applied Research Center
- Study start
- Apr 2007
- Study completion
- Sep 2007 (estimated)
- First posted
- 21 Aug 2007 (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 the effectiveness of ProAlgaZyme in increasing levels of HDL 'good' cholesterol and decreasing total cholesterol and C-reactive protein in patients with Metabolic Syndrome.
Detailed description
Cardiovascular disease (CVD) is the most common cause of mortality in the United States. In 1988, Reaven, et al. published findings that indicate a majority of individuals who developed CVD had multiple concurrent risk factors including dyslipidemia, hypertension, and hyperglycemia. Reaven, et al., defined this cluster of risk factors as Syndrome X and hypothesized that insulin resistance was the underlying factor in its development. Over time, metabolic syndrome has been used as a more meaningful term and additional risk factors have been associated with its diagnosis (Grundy, et al. 2004). Metabolic syndrome is an increasingly prevalent problem in the United States and other westernized nations. It is estimated that approximately 50 million Americans have metabolic syndrome. The risk factors linked to metabolic syndrome include:
- Abdominal obesity
- Atherogenic dyslipidemia (high triglycerides, low HDL cholesterol and high LDL cholesterol)
- Elevated blood pressure
- Insulin resistance with or without glucose intolerance
- Pro-thrombotic state (e.g., high fibrinogen or plasminogen activator inhibitor-1 in the blood)
- Pro-inflammatory state [e.g. elevated C-reactive protein (CRP)in the blood]
The management goals for metabolic syndrome include reducing the risk for developing CVD and type 2 diabetes. Therefore, therapy is directed at reducing LDL cholesterol, blood pressure and glucose as well as increasing HDL cholesterol levels. Additional interventions to control blood pressure and lipids provide the next line of treatment for patients with metabolic syndrome.
ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, will be evaluated in this trial for its effects on circulating lipids. According to the sponsor, ProAlgaZyme is expected to increase the circulating levels of HDL cholesterol while lowering total cholesterol and CRP. ProAlgaZyme was previously tested in a double blind, placebo controlled, pilot trial in 60 subjects with metabolic syndrome (30 subjects per arm), conducted at the University of Yaoundé, Cameroon. Statistically significant (p < 0.05 or better) improvements were seen in total cholesterol, HDL-C and C-reactive protein when compared to placebo. (In Press - Lipids in Health and Disease)
The present study will evaluate the effect of ProAlgaZyme versus placebo on blood lipids and hsCRP in subjects who meet the criteria for Metabolic Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Body mass index 28-40
- Subjects with at least 3 of the following parameters:
- Subjects with ability to comprehend and complete the questionnaires and forms
- Subjects whose schedules permit 4 visits to the study center over the duration of the trial
- Subjects who are likely to comply with study procedures and test article consumption
Key exclusion criteria (9 listed)
- Subjects with uncontrolled hypertension as defined as greater than 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been maintained)
- Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control
- Subjects with a history of hepatic or renal disease, insulin dependent diabetes, active cancer, HIV infection or blood dyscrasias
- Current use of lipid-lowering medications, anti-inflammatories such as low-dose aspirin, or herbal therapies known to affect inflammation or blood lipids 8 weeks prior to study entry
- Current use of Metformin
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 |
|---|---|---|
| ProAlgaZyme | Drug | – |
Primary outcome
HDL Cholesterol
Time frame: 12 weeks
3 secondary outcomes
Lipid Panel (Total Chol., LDL-Chol., Triglycerides, Total Chol./HDL-Chol. ratio)
Time frame: 12 weeks
C-Reactive Protein
Time frame: 12 weeks
Blood Pressure
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2007.
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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.
Terence Pertile, Ph.D. principal investigator
MAPS Applied Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProAlgaZyme in people with Metabolic Syndrome and Hyperlipidemia, run by Health Enhancement Products, Inc. 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 12 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Aug 2007. 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?
Results are not available in the source record.
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?
HDL 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 21 Aug 2007.