NCT00454831

Brief Summary

Chitosan is a natural product that is produced commercially through the deacetylation of chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan has a lipid-lowering effect. This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and effective in lowering LDL-cholesterol levels in patients with mild to moderately elevated cholesterol levels and who have not been previously treated with other lipid-lowering agents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2007

First QC Date

March 30, 2007

Last Update Submit

November 14, 2007

Conditions

Hypercholesterolemia

Keywords

HypercholesterolemiaLDL-cholesterolchitosanHEP-40

Outcome Measures

Primary Outcomes (1)

  • Percent change in serum LDL-C between the baseline and 4-week visit compared to placebo.

    4 weeks

Secondary Outcomes (5)

  • Percent change in serum LDL-C from baseline to 8- and 12-weeks of treatment compared to placebo

    12 weeks

  • Percent change in serum total cholesterol from baseline to 12 weeks of treatment compared to placebo

    12 weeks

  • Percent change in serum HDL-C from baseline to 12 weeks of treatment compared to placebo

    12 weeks

  • Percent change in serum triglycerides from baseline to 12 weeks of treatment compared to placebo

    12 weeks

  • Safety and tolerability over the 12-week active treatment period, as determined by treatment-emergent adverse events.

    12 weeks

Study Arms (5)

HEP 400mg TID

ACTIVE COMPARATOR

HEP-40 400 mg three times a day

Device: HEP-40 chitosan

HEP 800mg BID

ACTIVE COMPARATOR

HEP-40 800 mg twice a day

Device: HEP-40 chitosan

HEP 800mg TID

ACTIVE COMPARATOR

HEP-40 800 mg three times a day

Device: HEP-40 chitosan

HEP 2400mg QD

ACTIVE COMPARATOR

HEP-40 2400 mg once a day

Device: HEP-40 chitosan

Placebo

PLACEBO COMPARATOR

Placebo, three times a day

Device: HEP-40 chitosan

Interventions

HEP-40 chitosanDEVICE

Enzymatically Hydrolyzed Polychitosamine-40 kDa

Also known as: Libracol
HEP 2400mg QDHEP 400mg TIDHEP 800mg BIDHEP 800mg TIDPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with borderline, mild or moderate hypercholesterolemia, defined as LDL-C levels between 2.0 mmol/L and 4.5 mmol/L;
  • At low (≤10%) or moderate (11-19%) 10-year risk for cardiovascular disease according to the Framingham model;
  • Treatment-naïve for any lipid-lowering medications including statins, other pharmaceuticals or nutraceuticals;
  • Stable diet and willing to continue on the dietary regimen recommended by their physician (NCEP Step 1 Diet) for the duration of the study;
  • Woman of child bearing potential must be practicing effective birth control for a period of at least one month prior to initiation of the study.

You may not qualify if:

  • Any concomitant condition which in the opinion of the investigator would preclude the patient from successfully participating in the study;
  • Pregnant or that are breast feeding;
  • Participation in another clinical trial within 30 days from initiation of the study;
  • Known cardiac disease including: congestive heart failure, cardiac arrhythmias, unstable angina, myocardial infarction within the last 6 months, or uncontrolled malignant hypertension;
  • High risk of developing coronary artery disease;
  • Any condition affecting a major organ system, such as liver or kidney disease or malignancy;
  • Uncontrolled diabetes mellitus or newly diagnosed patients (within 3 months) or recent change in anti-diabetic pharmacotherapy within 3 months of screening;
  • Evidence of active renal disease indicated by serum creatinine \> 2.0 mg/dL;
  • Known HIV or Hepatitis B or C positive;
  • Concurrent use of corticosteroids;
  • Allergy or intolerance to crustaceans and/or seafood products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JSS Medical Research Inc.

Westmount, Quebec, H3Z 1R7, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jacques HF Lenis, MD

    Recherche Invascor Inc

    PRINCIPAL INVESTIGATOR

  • John S Sampalis, PhD

    JSS Medical Research Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 2, 2007

Study Start

February 1, 2006

Study Completion

September 1, 2007

Last Updated

November 16, 2007

Record last verified: 2007-11

Locations

CA(1)