Status:
COMPLETED
Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)
Lead Sponsor:
Stratum Nutrition
Collaborating Sponsors:
Kitozyme
Conditions:
Cardiovascular
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke, are the leading causes of death globally. Important risk factors for CVDs include elevated serum levels of...
Detailed Description
Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke, are the leading causes of death globally. Important risk factors for CVDs include elevated serum levels of...
Eligibility Criteria
Inclusion
- Male or female able to read, comprehend, and write English at sufficient level to complete study-related materials including informed consent
- Age: 21 - 70 years
- Body Mass Index: 18.5 - 34.9 kg/m2
- Fasting serum LDL-cholesterol: ≥ 130 - 189.9 mg/dl
- Willing to take supplement three times daily for 6 weeks and undergo other study-related procedures
- Is otherwise is in general good health as determined by the principal investigator
Exclusion
- Known hypersensitivity or intolerance to fiber or fiber-containing products
- Use of any investigational drugs prior to Visit 1
- Participation in any clinical trial while participating in this trial
- Member or family member of research staff or study sponsor involved in the conduct of this trial
- Greater than 5% change in body weight within 1 month of Visit 1
- Positive pregnancy test
- Is taking lipid-altering drug therapy within four weeks prior to Visit 1. Also excluded are supplements known to have significant lipid altering effects, such as niacin (\>100 mg per day), garlic (\> 600 mg per day), omega-3 fatty acids (\> 1 g omega-3 fatty acids per day), red yeast rice extract, phytostanols / phytosterols (\> 0.5 g per day), soluble fiber (\>1 g per day), chitosan (\> 1 g per day) and conjugated linoleic acid (CLA; \> 3 g per day)
- Excluded concurrent medications are: systemic corticosteroids (nasal and inhaled corticosteroids are permitted), orlistat, bile acid resins, no more than 1 g of prescription omega-3 fatty acids, cyclical or non-continuous hormone therapy (estrogen or testosterone)
- No more than 2 units of ethanol per day. Units are defined as 1.5 ounces of 80 proof alcohol per day, e.g. 2 twelve ounce cans of beer per day.
- Has a fasting serum triglyceride \> 300 mg/dl
- Has a diagnosis of type 1 or type 2 diabetes mellitus or fasting glucose \> 126 mg/dl
- Has a serum thyroid-stimulating hormone (TSH) higher than 1.5 times the upper limit of normal for the laboratory
- Is breast feeding, pregnant, or planning on becoming pregnant during the duration of the study
- Known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by Principle Investigator or Sub-investigator, or study site physician (e.g. clinically insignificant atherosclerotic lesions observed by imaging studies).
- History of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
- History of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study
- History if cancer within 5 years of Visit 1 (except for successfully treated basal and squamous cell carcinoma of the skin)
- Known human immunodeficiency virus (HIV) seropositivity
- History of bariatric surgery
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal
- Creatine kinase (CK) ≥ 3 times the upper limit of normal, unless explained by recent physical activity or trauma; or \> 5 times the upper limit of normal, irrespective of circumstance
- Creatinine ≥ 1.5 mg/dl
- Individuals who in the opinion of the principal investigator have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trail
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT01232309
Start Date
August 1 2010
End Date
January 1 2011
Last Update
October 23 2012
Active Locations (3)
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1
Provident Clinical Research and Consulting
Addison, Illinois, United States, 60101
2
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States, 40213
3
KGK Synergize
London, Ontario, Canada, N6A 5R8