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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 total cholesterol, low-density lipoprotein(LDL)-cholesterol, triglycerides, and low high-density lipoprotein (HDL)-cholesterol. Elevated "oxidized" LDL, a pro-inflammatory villain, has also emerged as an important risk factor for the development of CVDs. There is a growing need to identify safe and effective nutritional interventions that offer a clinical benefit aimed at reducing one more of the risk factors for CVDs. Data from many studies in humans have shown various health benefits provided by dietary fiber intake, including an inverse association with the risk of developing cardiovascular disease. The primary purpose of this study is to determine whether daily consumption for 6 weeks of chitin-glucan, a fiber purified from a microorganism, is effective at reducing the amount of oxidized LDL in humans with borderline-to-high LDL-cholesterol. The effects of chitin-glucan on other cardiovascular risk factors will also be evaluated.

Condition or disease	Intervention/treatment	Phase
Cardiovascular	Dietary Supplement: Chitin-Glucan; Dietary Supplement: Low Dose Chitin-Glucan; Dietary Supplement: Low Dose Chitin-Glucan + Olive Extract; Dietary Supplement: Placebo	Not Applicable

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Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: High Dose Chitin-Glucan; Daily oral dose of 4.5 g of chitin-glucan	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	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	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)	Dietary Supplement: Placebo; 3 x 500 mg capsules (tid); Other Name: Rice Flour

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Oxidized LDL [ Time Frame: After 4 and 6 weeks ]

Secondary Outcome Measures :

1. Total cholesterol [ Time Frame: After 4 and 6 weeks ]
2. LDL-cholesterol [ Time Frame: After 4 and 6 weeks ]
3. HDL-cholesterol [ Time Frame: After 4 and 6 weeks ]
4. Triglycerides [ Time Frame: After 4 and 6 weeks ]
5. Glucose [ Time Frame: After 4 and 6 weeks ]
6. Insulin [ Time Frame: After 4 and 6 weeks ]
7. F2-isoprostanes (urine) [ Time Frame: After 4 and 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Stratum Nutrition

Kitozyme

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Stratum Nutrition 

KitoZyme 

KGK Synergize 

Provident Clinical Research and Consulting 

Louisville Metabolic and Atherosclerosis Research Center 

Publications of Results:

Bays HE, Evans JL, Maki KC, Evans M, Maquet V, Cooper R, Anderson JW. Chitin-glucan fiber effects on oxidized low-density lipoprotein: a randomized controlled trial. Eur J Clin Nutr. 2013 Jan;67(1):2-7. doi: 10.1038/ejcn.2012.121. Epub 2012 Sep 5.

Other Publications:

Berecochea-Lopez A, Decordé K, Ventura E, Godard M, Bornet A, Teissèdre PL, Cristol JP, Rouanet JM. Fungal chitin-glucan from Aspergillus niger efficiently reduces aortic fatty streak accumulation in the high-fat fed hamster, an animal model of nutritionally induced atherosclerosis. J Agric Food Chem. 2009 Feb 11;57(3):1093-8. doi: 10.1021/jf803063v.

Jonker D, Kuper CF, Maquet V, Nollevaux G, Gautier S. Subchronic (13-week) oral toxicity study in rats with fungal chitin-glucan from Aspergillus niger. Food Chem Toxicol. 2010 Oct;48(10):2695-701. doi: 10.1016/j.fct.2010.06.042. Epub 2010 Jun 30.

Anderson JW, Baird P, Davis RH Jr, Ferreri S, Knudtson M, Koraym A, Waters V, Williams CL. Health benefits of dietary fiber. Nutr Rev. 2009 Apr;67(4):188-205. doi: 10.1111/j.1753-4887.2009.00189.x. Review.

Huang H, Mai W, Liu D, Hao Y, Tao J, Dong Y. The oxidation ratio of LDL: a predictor for coronary artery disease. Dis Markers. 2008;24(6):341-9.

Neyrinck AM, Possemiers S, Verstraete W, De Backer F, Cani PD, Delzenne NM. Dietary modulation of clostridial cluster XIVa gut bacteria (Roseburia spp.) by chitin-glucan fiber improves host metabolic alterations induced by high-fat diet in mice. J Nutr Biochem. 2012 Jan;23(1):51-9. doi: 10.1016/j.jnutbio.2010.10.008. Epub 2011 Mar 15.

Responsible Party:	Stratum Nutrition
ClinicalTrials.gov Identifier:	NCT01232309 History of Changes
Other Study ID Numbers:	KSN-CS-001
First Posted:	November 2, 2010
Last Update Posted:	October 23, 2012
Last Verified:	October 2012

Keywords provided by Stratum Nutrition:

Arterial Health; Fiber; Chitin-glucan; oxidized LDL