Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)

Inclusion Criteria:

1. Male or female able to read, comprehend, and write English at sufficient level to complete study-related materials including informed consent
2. Age: 21 - 70 years
3. Body Mass Index: 18.5 - 34.9 kg/m2
4. Fasting serum LDL-cholesterol: ≥ 130 - 189.9 mg/dl
5. Willing to take supplement three times daily for 6 weeks and undergo other study-related procedures
6. Is otherwise is in general good health as determined by the principal investigator

Exclusion Criteria:

1. Known hypersensitivity or intolerance to fiber or fiber-containing products
2. Use of any investigational drugs prior to Visit 1
3. Participation in any clinical trial while participating in this trial
4. Member or family member of research staff or study sponsor involved in the conduct of this trial
5. Greater than 5% change in body weight within 1 month of Visit 1
6. Positive pregnancy test
7. 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)
8. 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)
9. 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.
10. Has a fasting serum triglyceride > 300 mg/dl
11. Has a diagnosis of type 1 or type 2 diabetes mellitus or fasting glucose > 126 mg/dl
12. Has a serum thyroid-stimulating hormone (TSH) higher than 1.5 times the upper limit of normal for the laboratory
13. Is breast feeding, pregnant, or planning on becoming pregnant during the duration of the study
14. 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).
15. History of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
16. History of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study
17. History if cancer within 5 years of Visit 1 (except for successfully treated basal and squamous cell carcinoma of the skin)
18. Known human immunodeficiency virus (HIV) seropositivity
19. History of bariatric surgery
20. Aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal
21. 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
22. Creatinine ≥ 1.5 mg/dl
23. 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