Metabolic Syndrome XNCT00489333
ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome
A study testing ProAlgaZyme in people with Metabolic Syndrome X, run by Health Enhancement Products, Inc. at 1 site in Cameroon.
Trial summary
The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome and indicators of cardiovascular health including: body weight and fat, blood lipids, inflammatory markers such as hsCRP, blood… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- ProAlgaZyme
- How many people
- 52 participants
- Where
- 1 siteCameroon
- Study dates
- May 2006to Sep 2006
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet 3 of the following criteria:
- BMI ≥30 kg/m2
- HDL Cholesterol of <40
- Triglycerides >150 mg/dl
- Fasting blood glucose >100 mg/dl
- Blood pressure >130/85 mm Hg
Show all 9Show fewer
- Total Cholesterol of >200 mg/dl
- LDL Cholesterol of >160 mg/dl
- Interleukin 6 (IL-6) >5pg/mL
Who cannot join
- Morbidly obese: BMI >40 kg/m2
- Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study.
- Enrolled in another clinical study in the past 6 months.
- Pregnant, actively infected, on medication that interfered with healing (for example, steroids), were inflicted with systemic disease such as AIDS, HIV, active hepatitis or active malignancy (clinical signs within the past 5 years), or suffered from diabetes mellitus requiring daily insulin management.
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
Yaoundé
About this study
Official title: The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health
The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome and indicators of cardiovascular health including: body weight and fat, blood lipids, inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.
Read the detailed description
Metabolic syndrome, a set of symptoms strongly associated with increased risk for both cardiovascular disease and diabetes, is generally linked to obesity and has become a serious problem in many industrialized countries. Agents that aid in weight loss or help to normalize blood lipids or inflammation may reduce the risk of metabolic syndrome and therefore, reduce the risk of cardiovascular disease and diabetes. This study is a single-center, double-blind, placebo-controlled, parallel design, to evaluate the effects of ProAlgaZyme (4 fl. oz. daily) on metabolic syndrome and markers of cardiovascular health including blood lipids, inflammatory markers and anthropometric measurements.
Comparisons: ProAlgaZyme vs. placebo [Time frame: 10 weeks]
- Conditions
- Metabolic Syndrome X
- Being tested
- ProAlgaZyme
- Keywords
- ProAlgaZyme, Metabolic syndrome, Inflammation, Cardiovascular, hsCRP, Lipids, Algae
- Medical subject headings
- Metabolic Syndrome, Inflammation
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.
hsCRP
Measured: 10 weeks
Lipids (total cholesterol, triglycerides HDL-C, LDL-C)
Measured: 10 weeks
Anthropometric measurements (weight/BMI, % body fat, blood pressure)
Measured: 10 weeks
Fasting Blood Glucose
Measured: 10 weeks
Secondary outcomes (4)
Insulin
Measured: 10 weeks
Interleukin-6 (IL-6)
Measured: 10 weeks
TNF-alpha
Measured: 10 weeks
RBC Sedimentation Rate
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startMay 2006
- Study completionSep 2006
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 Metabolic Syndrome XStudies 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
- Double blind
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Enhancement Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Yaounde
- Investigators
- Julius Oben, Ph.D., Principal investigator, Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489333
- Sponsor's protocol ID
- H-0001-01
- Other IDs
- 087/2006
- Status last verified
- Jun 2007
- First submitted
- 19 Jun 2007
- Last updated
- 21 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Oben J, Enonchong E, Kuate D, Mbanya D, Thomas TC, Hildreth DJ, Ingolia TD, Tempesta MS. The effects of ProAlgaZyme novel algae infusion on metabolic syndrome and markers of cardiovascular health. Lipids Health Dis. 2007 Sep 5;6:20. doi: 10.1186/1476-511X-6-20.
PubMed 17803818
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health
- ClinicalTrials.gov ID
- NCT00489333
- Acronym / sponsor ID
- H-0001-01
- Conditions
- Metabolic Syndrome X
- Keywords
- ProAlgaZyme, Metabolic syndrome, Inflammation, Cardiovascular, hsCRP, Lipids, Algae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Health Enhancement Products, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Yaounde
- Study start
- May 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 21 Jun 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 compare the effects of supplementation with ProAlgaZyme (a novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome and indicators of cardiovascular health including: body weight and fat, blood lipids, inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.
Detailed description
Metabolic syndrome, a set of symptoms strongly associated with increased risk for both cardiovascular disease and diabetes, is generally linked to obesity and has become a serious problem in many industrialized countries. Agents that aid in weight loss or help to normalize blood lipids or inflammation may reduce the risk of metabolic syndrome and therefore, reduce the risk of cardiovascular disease and diabetes. This study is a single-center, double-blind, placebo-controlled, parallel design, to evaluate the effects of ProAlgaZyme (4 fl. oz. daily) on metabolic syndrome and markers of cardiovascular health including blood lipids, inflammatory markers and anthropometric measurements.
Comparisons: ProAlgaZyme vs. placebo [Time frame: 10 weeks]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants must meet 3 of the following criteria:
Key exclusion criteria (4 listed)
- Morbidly obese: BMI >40 kg/m2
- Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study.
- Enrolled in another clinical study in the past 6 months.
- Pregnant, actively infected, on medication that interfered with healing (for example, steroids), were inflicted with systemic disease such as AIDS, HIV, active hepatitis or active malignancy (clinical signs within the past 5 years), or suffered from diabetes mellitus requiring daily insulin management.
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
hsCRP
Time frame: 10 weeks
Lipids (total cholesterol, triglycerides HDL-C, LDL-C)
Time frame: 10 weeks
Anthropometric measurements (weight/BMI, % body fat, blood pressure)
Time frame: 10 weeks
Fasting Blood Glucose
Time frame: 10 weeks
4 secondary outcomes
Insulin
Time frame: 10 weeks
Interleukin-6 (IL-6)
Time frame: 10 weeks
TNF-alpha
Time frame: 10 weeks
RBC Sedimentation Rate
Time frame: 10 weeks
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 21 Jun 2007.
- Derived from this study: PubMed 17803818Oben J, Enonchong E, Kuate D, Mbanya D, Thomas TC, Hildreth DJ, Ingolia TD, Tempesta MS. The effects of ProAlgaZyme novel algae infusion on metabolic syndrome and markers of cardiovascular health. Lipids Health Dis. 2007 Sep 5;6:20. doi: 10.1186/1476-511X-6-20.
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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.
Julius Oben, Ph.D. principal investigator
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
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 X, run by Health Enhancement Products, Inc. at 1 site in Cameroon.
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 9 inclusion and 4 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 21 Jun 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 Cameroon. 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?
hsCRP (time frame: 10 weeks). The study lists 4 primary outcomes in all. 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 NCT00489333, 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 21 Jun 2007.