NCT00518960

Unknown

The Effects of ProAlgaZyme on HDL Cholesterol in Individuals...

Health Enhancement Products, Inc.Source

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Other study identifiers

Sponsor study identifier

H-0003-02

Secondary identifiers

MARC007-003

Study Type

interventional

Actual enrollment (reported)

28

Locations

1 country

Sites

1

Timeline

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

September 2007

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Actual enrollment (reported): 28 participants
Study completion date: September 2007
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 17, 2007
Actual (reported)
First Posted
August 21, 2007
Actual (reported)
Study Completion
September 2007
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: August 21, 2007
Status Verified: August 2007
Last Update Submitted: August 17, 2007

Conditions

Hyperlipidemia Metabolic Syndrome

Keywords

ProAlgaZymeAlgaeHigh density lipoprotein; HDLC-Reactive Protein; CRPHyperlipidemiaMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

HDL Cholesterol
12 weeks

Secondary Outcomes (3)

Lipid Panel (Total Chol., LDL-Chol., Triglycerides, Total Chol./HDL-Chol. ratio)
12 weeks
C-Reactive Protein
12 weeks
Blood Pressure
12 weeks

Interventions

ProAlgaZymeDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Body mass index 28-40
Subjects with at least 3 of the following parameters:

Sponsors & Collaborators

Health Enhancement Products, Inc.
Industrylead
MAPS Applied Research Center
Industrycollaborator

Study Sites (1)

MAPS Applied Research Center (MARC)

Edina, Minnesota, 55435, United States

MeSH Terms

Conditions

Metabolic SyndromeHyperlipidemias

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders

Study Officials

Terence Pertile, Ph.D.
MAPS Applied Research Center
PRINCIPAL INVESTIGATOR

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 17, 2007

First Posted

August 21, 2007

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Completed

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Not ApplicableCompleted

NCT00413400

Study of TNF-Antagonism in the Metabolic Syndrome (II)

Not ApplicableCompleted

NCT01152073

A Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)

Not ApplicableCompleted

NCT00175071

Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers

Not ApplicableCompleted

NCT00433173

Insulin Sensitivity in Men With the Metabolic Syndrome

Not ApplicableSuspended

NCT00794963

Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia

Not ApplicableTerminated

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

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

You may not qualify if:

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)
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

Contact the study team to confirm eligibility.

Study Completion

September 2007

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

August 21, 2007

Record last verified: 2007-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00518960
Data provider: ClinicalTrials.gov
Source updated: 2007-08-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:58 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations