NCT01232309

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

October 30, 2010

Last Update Submit

October 22, 2012

Conditions

Cardiovascular

Keywords

Arterial HealthFiberChitin-glucanoxidized LDL

Outcome Measures

Primary Outcomes (1)

  • Oxidized LDL

    After 4 and 6 weeks

Secondary Outcomes (7)

  • Total cholesterol

    After 4 and 6 weeks

  • LDL-cholesterol

    After 4 and 6 weeks

  • HDL-cholesterol

    After 4 and 6 weeks

  • Triglycerides

    After 4 and 6 weeks

  • Glucose

    After 4 and 6 weeks

  • +2 more secondary outcomes

Study Arms (4)

High Dose Chitin-Glucan

ACTIVE COMPARATOR

Daily oral dose of 4.5 g of chitin-glucan

Dietary Supplement: Chitin-Glucan

Low Dose Chitin-Glucan

ACTIVE COMPARATOR

Daily oral dose of 1.5 g chitin-glucan

Dietary Supplement: Low Dose Chitin-Glucan

Low Dose Chitin-Glucan + Olive Extract

EXPERIMENTAL

Daily oral dose of 1.5 g chitin-glucan + 135 mg olive extract

Dietary Supplement: Low Dose Chitin-Glucan + Olive Extract

Placebo

PLACEBO COMPARATOR

Placebo (Rice Flour)

Dietary Supplement: Placebo

Interventions

Chitin-GlucanDIETARY_SUPPLEMENT

3 x 500 mg capsules (tid) = 4.5 mg daily dose

Also known as: Artinia
High Dose Chitin-Glucan
Low Dose Chitin-GlucanDIETARY_SUPPLEMENT

3 x 167 mg capsules (tid) = 1.5 g daily dose

Also known as: Artinia
Low Dose Chitin-Glucan
Low Dose Chitin-Glucan + Olive ExtractDIETARY_SUPPLEMENT

3 x 167 mg capsules (tid) = 1.5 g daily dose (C-G) + 135 mg olive extract

Also known as: Artinia Green
Low Dose Chitin-Glucan + Olive Extract
PlaceboDIETARY_SUPPLEMENT

3 x 500 mg capsules (tid)

Also known as: Rice Flour
Placebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Provident Clinical Research and Consulting

Addison, Illinois, 60101, United States

Location

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, 40213, United States

Location

KGK Synergize

London, Ontario, N6A 5R8, Canada

Location

Related Publications (6)

  • Berecochea-Lopez A, Decorde K, Ventura E, Godard M, Bornet A, Teissedre 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.

    PMID: 19154104BACKGROUND

  • 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.

    PMID: 20600523BACKGROUND

  • 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.

    PMID: 19335713BACKGROUND

  • 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. doi: 10.1155/2008/371314.

    PMID: 18688083BACKGROUND

  • 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.

    PMID: 21411304BACKGROUND

  • 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.

    PMID: 22948945RESULT

Related Links

MeSH Terms

Interventions

carboxymethyl-chitin-glucanolive extractFlour

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Joseph L Evans, PhD

    Stratum Nutrition

    STUDY DIRECTOR

  • James Anderson, MD

    Consultant / Advisor (Stratum and KitoZyme)

    STUDY CHAIR

  • Ray Cooper, PhD

    Stratum Nutrition

    STUDY DIRECTOR

  • Veronique Maquet, PhD

    Kitozyme

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2010

First Posted

November 2, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

CA(1)US(2)