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.
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
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 group | Role | What they receive |
|---|---|---|
| High Dose Chitin-Glucan | Active comparator | Daily oral dose of 4.5 g of chitin-glucan Receives: Dietary Supplement: Chitin-Glucan |
| Low Dose Chitin-Glucan | Active comparator | Daily oral dose of 1.5 g chitin-glucan Receives: 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 Receives: Dietary Supplement: Low Dose Chitin-Glucan + Olive Extract |
| Placebo | Placebo comparator | Placebo (Rice Flour) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidized LDL
Measured: After 4 and 6 weeks
Secondary outcomes (7)
Total cholesterol
Measured: After 4 and 6 weeks
LDL-cholesterol
Measured: After 4 and 6 weeks
HDL-cholesterol
Measured: After 4 and 6 weeks
Triglycerides
Measured: After 4 and 6 weeks
Glucose
Measured: After 4 and 6 weeks
Insulin
Measured: After 4 and 6 weeks
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.
- First posted2 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Stratum Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kitozyme
- Responsible party
- Sponsor
- Investigators
- Joseph L Evans, PhD, Study director, Stratum NutritionJames Anderson, MD, Study chair, Consultant / Advisor (Stratum and KitoZyme)Ray Cooper, PhD, Study director, Stratum NutritionVeronique Maquet, PhD, Study director, Kitozyme
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 19154104Jonker 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 20600523Anderson 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 19335713Huang 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 18688083Neyrinck 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 21411304Bays 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)
- ClinicalTrials.gov ID
- NCT01232309
- Acronym / sponsor ID
- KSN-CS-001
- Conditions
- Cardiovascular
- Keywords
- Arterial Health, Fiber, Chitin-glucan, oxidized LDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Stratum NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Kitozyme
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Dose Chitin-Glucan | Active comparator | Dietary Supplement: Chitin-GlucanDaily oral dose of 4.5 g of chitin-glucan |
| Low Dose Chitin-Glucan | Active comparator | Dietary Supplement: Low Dose Chitin-GlucanDaily oral dose of 1.5 g chitin-glucan |
| Low Dose Chitin-Glucan + Olive Extract | Experimental | Dietary Supplement: Low Dose Chitin-Glucan + Olive ExtractDaily oral dose of 1.5 g chitin-glucan + 135 mg olive extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (Rice Flour) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitin-GlucanAlso: Artinia3 x 500 mg capsules (tid) = 4.5 mg daily dose | Dietary supplement | High Dose Chitin-Glucan |
| Low Dose Chitin-GlucanAlso: Artinia3 x 167 mg capsules (tid) = 1.5 g daily dose | Dietary supplement | Low Dose Chitin-Glucan |
| Low Dose Chitin-Glucan + Olive ExtractAlso: Artinia Green3 x 167 mg capsules (tid) = 1.5 g daily dose (C-G) + 135 mg olive extract | Dietary supplement | Low Dose Chitin-Glucan + Olive Extract |
| PlaceboAlso: Rice Flour3 x 500 mg capsules (tid) | Dietary supplement | Placebo |
Primary outcome
Oxidized LDL
Time frame: After 4 and 6 weeks
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
- Background: PubMed 19154104Berecochea-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.
- Background: PubMed 20600523Jonker 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.
- Background: PubMed 19335713Anderson 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.
- Background: PubMed 18688083Huang 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.
- Background: PubMed 21411304Neyrinck 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.
- Results publication: PubMed 22948945Bays 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.
- Stratum NutritionLink provided by the sponsor.
- KitoZymeLink provided by the sponsor.
- KGK SynergizeLink provided by the sponsor.
- Provident Clinical Research and ConsultingLink provided by the sponsor.
- Louisville Metabolic and Atherosclerosis Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph L Evans, PhD study director
Stratum Nutrition
James Anderson, MD study chair
Consultant / Advisor (Stratum and KitoZyme)
Ray Cooper, PhD study director
Stratum Nutrition
3 sites in 2 countries: see every site and its status.
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.