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CardiovascularNCT01232309

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

A study testing Chitin-Glucan, Low Dose Chitin-Glucan and Low Dose Chitin-Glucan + Olive Extract in people with Cardiovascular, run by Stratum Nutrition at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular
What is being tested?
Chitin-Glucan, Low Dose Chitin-Glucan and Low Dose Chitin-Glucan + Olive Extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
3 sitesin 2 countries
Study dates
Aug 2010to Jan 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites
  • Provident Clinical Research and Consulting

    Addison, Illinois, 60101

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213

Other trials in United States

Canada1 site
  • KGK Synergize

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)

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.

Read the detailed description

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 levels. Oxidized LDL has also been identified as a risk factor for CVDs. There is a growing need to identify safe and effective interventions that offer a clinical benefit aimed at reducing one more of the risk factors for CVDs.

Oxidized LDL is a unique plaque-specific protein produced in the arterial wall by the oxidative modification of the apoB-100 moiety of native LDL mediated by reactive oxygen species. Oxidized LDL is a powerful atherogenic protein, which is directly involved in the initiation and progression of atherosclerosis, the main cause of coronary artery disease (CAD). It is now widely believed that for native LDL to be atherogenic, it must be converted to oxidized LDL. Oxidized LDL is found in atherosclerotic lesions and in the circulation, but not in normal arteries. Oxidized LDL is both a biomarker of accelerated atherosclerosis and a mediator of the atherosclerotic disease process. In 1998, Holvoet et al demonstrated for the first time that elevated circulating levels of oxidized LDL were found in most untreated patients with both stable CAD and acute coronary syndromes (unstable angina; acute myocardial infarction). In this landmark study, oxidized LDL levels were measured in plasma with an ELISA procedure using the oxidized LDL-specific, murine monoclonal antibody, 4E6. Mercodia's commercially available oxidized LDL ELISA kits use Holvoet's monoclonal antibody, 4E6, which is specific for oxidatively modified LDL. The 4E6 antibody is directed against a conformational epitope in the apoprotein(apo)B-100 moiety of LDL that is generated as a consequence of aldehyde substitution of the lysine residues of apoB-100.

Data from epidemiological studies have shown various health benefits provided by dietary fiber intake, including an inverse association with the risk of CVDs. As shown in several well-controlled clinical trials, various water-soluble dietary fibers reduced total cholesterol and LDL-cholesterol while HDL-cholesterol and triglycerides were not significantly influenced. Recently, the European Food Safety Authority (EFSA) authorized a health claim related to the maintenance of normal blood cholesterol concentrations for soluble cereal fibres, particularly beta-glucans from oat and barley. The beta-glucans in these cereals are non-starch polysaccharides consisting of (1→3,1→4)-beta-D-linked glucose units.

Few studies have addressed potential favorable effects of beta-glucans from micro-organisms on CVD risk factors. One clinical study examined the effects of yeast-derived beta-glucan, a glucose polymer with beta-(1→3,1→6) linkages, on serum lipids in 15 hypercholesterolemic obese men. At the end of the 8-week treatment period (15 g fiber/day in addition to the normal diet), total cholesterol levels were decreased whereas HDL-cholesterol, LDL-cholesterol and triglycerides did not differ significantly from the baseline values. A number of animal studies showed that consumption of fungi or fungal extract can lower blood cholesterol or reduce aortic atherosclerotic lesions in rabbits fed a high-cholesterol diet or in atherosclerosis-susceptible apolipoprotein E-deficient mice fed a normal. It should be noted that the fungal component(s) causing these effects have not been identified or characterized (whole mushrooms or an impure extract were tested).

Chitin-glucan is a natural component of the cell wall of microscopic fungi. Chitin-glucan can be regarded as an insoluble dietary fiber. In hamsters fed an atherogenic diet, chitin-glucan mixed with food lowered plasma triglycerides and markedly reduced the diet-induced formation of aortic fatty streak lesions. It also reduced aortic cholesterol, cardiac superoxide anion production and hepatic malondialdehyde, and increased hepatic antioxidant enzyme activities (glutathione peroxidase and superoxide dismutase). Although oxidized LDL was not measured in this study, data from an early clinical trial indicated that consumption of chitin-glucan for 28 days decreased circulating oxidized LDL by approximately 26% in healthy, normo-cholesterolemic young males.

To confirm these results in a randomized, double-blind, placebo-controlled study using males and females with broader inclusion criteria, chitin-glucan will be evaluated alone (at 1.5 and 4.5 grams per day), and in combination with olive extract (chitin-glucan at 1.5 gram per day + olive extract at 135 mg per day). There is a large body of evidence that indicates that olive oil recapitulates many of the beneficial effects on human health, including a reduced risk for developing CVDs, that are reported for intake of the Mediterranean Diet. Numerous studies performed in vitro and in vivo have concluded that polyphenolic compounds present in extra virgin olive oil play an important role in the prevention of atherosclerotic damage through their inhibition of LDL oxidation. Tyrosol and hydroxytyrosol show dose-dependent activity in this regard and are considered potent antioxidants, demonstrating activity in the micromolar range. Thus, there is a solid scientific and clinical rationale to evaluate both chitin-glucan alone and in combination with olive extract for their ability to reduce oxidized LDL.

Conditions
Cardiovascular
Being tested
Chitin-Glucan, Low Dose Chitin-Glucan, Low Dose Chitin-Glucan + Olive Extract, Placebo
Keywords
Arterial Health, Fiber, Chitin-glucan, oxidized LDL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chitin-GlucanDietary supplement

    Also called Artinia

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

  • Low Dose Chitin-GlucanDietary supplement

    Also called Artinia

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

  • Low Dose Chitin-Glucan + Olive ExtractDietary supplement

    Also called Artinia Green

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

  • PlaceboDietary supplement

    Also called Rice Flour

    3 x 500 mg capsules (tid)

Study groups in NCT01232309
Study groupRoleWhat they receive
High Dose Chitin-GlucanActive comparatorDaily oral dose of 4.5 g of chitin-glucan
Receives: Dietary Supplement: Chitin-Glucan
Low Dose Chitin-GlucanActive comparatorDaily oral dose of 1.5 g chitin-glucan
Receives: Dietary Supplement: Low Dose Chitin-Glucan
Low Dose Chitin-Glucan + Olive ExtractExperimentalDaily oral dose of 1.5 g chitin-glucan + 135 mg olive extract
Receives: Dietary Supplement: Low Dose Chitin-Glucan + Olive Extract
PlaceboPlacebo comparatorPlacebo (Rice Flour)
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxidized LDL

    Measured: After 4 and 6 weeks

Secondary outcomes (7)
  1. Total cholesterol

    Measured: After 4 and 6 weeks

  2. LDL-cholesterol

    Measured: After 4 and 6 weeks

  3. HDL-cholesterol

    Measured: After 4 and 6 weeks

  4. Triglycerides

    Measured: After 4 and 6 weeks

  5. Glucose

    Measured: After 4 and 6 weeks

  6. Insulin

    Measured: After 4 and 6 weeks

  7. F2-isoprostanes (urine)

    Measured: After 4 and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01232309
Sponsor's protocol ID
KSN-CS-001
Status last verified
Oct 2012
First submitted
30 Oct 2010
Last updated
23 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19154104
  • 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.

    PubMed 20600523
  • 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.

    PubMed 19335713
  • 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.

    PubMed 18688083
  • 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.

    PubMed 21411304
  • 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.

    PubMed 22948945

Questions about this trial

What is this clinical trial studying?

A study testing Chitin-Glucan, Low Dose Chitin-Glucan and Low Dose Chitin-Glucan + Olive Extract in people with Cardiovascular, run by Stratum Nutrition at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxidized LDL (time frame: After 4 and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01232309, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.

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