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

This study has been completed.
Sponsor:
Collaborator:
KitoZyme
Information provided by (Responsible Party):
Stratum Nutrition
ClinicalTrials.gov Identifier:
NCT01232309
First received: October 30, 2010
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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 Intervention
Cardiovascular
Dietary Supplement: Chitin-Glucan
Dietary Supplement: Low Dose Chitin-Glucan
Dietary Supplement: Low Dose Chitin-Glucan + Olive Extract
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Stratum Nutrition:

Primary Outcome Measures:
  • Oxidized LDL [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cholesterol [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]
  • LDL-cholesterol [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]
  • F2-isoprostanes (urine) [ Time Frame: After 4 and 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232309

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

Additional Information:
Publications:
Responsible Party: Stratum Nutrition
ClinicalTrials.gov Identifier: NCT01232309     History of Changes
Other Study ID Numbers: KSN-CS-001
Study First Received: October 30, 2010
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stratum Nutrition:
Arterial Health
Fiber
Chitin-glucan
oxidized LDL

ClinicalTrials.gov processed this record on July 23, 2014