NCT00518960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 21, 2007

Status Verified

August 1, 2007

First QC Date

August 17, 2007

Last Update Submit

August 17, 2007

Conditions

Metabolic SyndromeHyperlipidemia

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

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:
  • 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.

Sponsors & Collaborators

Study Sites (1)

MAPS Applied Research Center (MARC)

Edina, Minnesota, 55435, United States

Location

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

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 1, 2007

Study Completion

September 1, 2007

Last Updated

August 21, 2007

Record last verified: 2007-08

Locations

US(1)