Efficacy and Safety of HEP-40 Chitosan for Mild to Moderately Elevated Cholesterol
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.
Description
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 by binding to fatty acids and cholesterol in the gastrointestinal tract and restricting their absorption.
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 who have not been previously treated with lipid-lowering agents and who have cholesterol levels that are mild to moderately above the levels recommended by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines.
This is a multi-centre, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase where patients will be instructed to maintain a stable diet, patients will be randomized to one of the following study groups for a 12-week Active Treatment Phase:
- HEP-40 400 mg three times a day (400 mg TID)
- HEP-40 800 mg twice a day (800 mg BID)
- HEP-40 800 mg three times a day (800 mg TID)
- HEP-40 2400 mg once a day (2400 mg QD)
- Placebo, three times a day (placebo)
The primary objective is to evaluate the clinical benefit of administering HEP-40 chitosan at different doses and at different dosing regimens compared with placebo. Clinical benefit will be defined as the reduction in LDL-cholesterol after 4 weeks of active treatment.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Hypercholesterolemia
Intervention
HEP-40 chitosan
Location
JSS Medical Research Inc.
Westmount
Quebec
Canada
H3Z 1R7
Status
Completed
Source
DNP Canada
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00454831
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Chitin
A linear polysaccharide of beta-1->4 linked units of ACETYLGLUCOSAMINE. It is the second most abundant biopolymer on earth, found especially in INSECTS and FUNGI. When deacetylated it is called CHITOSAN.
Chitosan
Deacetylated CHITIN, a linear polysaccharide of deacetylated beta-1,4-D-glucosamine. It is used in HYDROGEL and to treat WOUNDS.
Hypercholesterolemia
A condition with abnormally high levels of CHOLESTEROL in the blood. It is defined as a cholesterol value exceeding the 95th percentile for the population.
Safflower Oil
An oily liquid extracted from the seeds of the safflower, Carthamus tinctorius. It is used as a dietary supplement in the management of HYPERCHOLESTEROLEMIA. It is used also in cooking, as a salad oil, and as a vehicle for medicines, paints, varnishes, etc. (Dorland, 28th ed & Random House Unabridged Dictionary, 2d ed)
Pectins
High molecular weight polysaccharides present in the cell walls of all plants. Pectins cement cell walls together. They are used as emulsifiers and stabilizers in the food industry. They have been tried for a variety of therapeutic uses including as antidiarrheals, where they are now generally considered ineffective, and in the treatment of hypercholesterolemia.
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