Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)
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ClinicalTrials.gov Identifier: NCT01232309 |
Recruitment Status :
Completed
First Posted : November 2, 2010
Last Update Posted : October 23, 2012
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular | Dietary Supplement: Chitin-Glucan Dietary Supplement: Low Dose Chitin-Glucan Dietary Supplement: Low Dose Chitin-Glucan + Olive Extract Dietary Supplement: Placebo | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 135 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL) |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: High Dose Chitin-Glucan
Daily oral dose of 4.5 g of chitin-glucan
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Dietary Supplement: Chitin-Glucan
3 x 500 mg capsules (tid) = 4.5 mg daily dose
Other Name: Artinia |
Active Comparator: Low Dose Chitin-Glucan
Daily oral dose of 1.5 g chitin-glucan
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Dietary Supplement: Low Dose Chitin-Glucan
3 x 167 mg capsules (tid) = 1.5 g daily dose
Other Name: Artinia |
Experimental: Low Dose Chitin-Glucan + Olive Extract
Daily oral dose of 1.5 g chitin-glucan + 135 mg olive extract
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Dietary Supplement: Low Dose Chitin-Glucan + Olive Extract
3 x 167 mg capsules (tid) = 1.5 g daily dose (C-G) + 135 mg olive extract
Other Name: Artinia Green |
Placebo Comparator: Placebo
Placebo (Rice Flour)
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Dietary Supplement: Placebo
3 x 500 mg capsules (tid)
Other Name: Rice Flour |
- Oxidized LDL [ Time Frame: After 4 and 6 weeks ]
- Total cholesterol [ Time Frame: After 4 and 6 weeks ]
- LDL-cholesterol [ Time Frame: After 4 and 6 weeks ]
- HDL-cholesterol [ Time Frame: After 4 and 6 weeks ]
- Triglycerides [ Time Frame: After 4 and 6 weeks ]
- Glucose [ Time Frame: After 4 and 6 weeks ]
- Insulin [ Time Frame: After 4 and 6 weeks ]
- F2-isoprostanes (urine) [ Time Frame: After 4 and 6 weeks ]

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Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232309
United States, Illinois | |
Provident Clinical Research and Consulting | |
Addison, Illinois, United States, 60101 | |
United States, Kentucky | |
Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | |
Louisville, Kentucky, United States, 40213 | |
Canada, Ontario | |
KGK Synergize | |
London, Ontario, Canada, N6A 5R8 |
Study Director: | Joseph L Evans, PhD | Stratum Nutrition | |
Study Chair: | James Anderson, MD | Consultant / Advisor (Stratum and KitoZyme) | |
Study Director: | Ray Cooper, PhD | Stratum Nutrition | |
Study Director: | Veronique Maquet, PhD | Kitozyme |
Publications of Results:
Other Publications:
Responsible Party: | Stratum Nutrition |
ClinicalTrials.gov Identifier: | NCT01232309 |
Other Study ID Numbers: |
KSN-CS-001 |
First Posted: | November 2, 2010 Key Record Dates |
Last Update Posted: | October 23, 2012 |
Last Verified: | October 2012 |
Arterial Health Fiber Chitin-glucan oxidized LDL |