Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)
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.


Options:
A: Inclusion Criteria:

* BMI of 23-35 kg/m2

Exclusion Criteria:

* Subjects taking any drugs, botanicals or nutraceutical known to influence body weight or blood pressure
* significant history of eating disorders
* strenuous exercise to lose weight
* lipid-lowering medication
* use of steroids and other agents that may influence lipid metabolism
* hyperlipidemia
* hyperglycemia
* diabetes mellitus
* cardiovascular disease
* major systemic diseases
* gastrointestinal problems
* liver and renal failure
B: Inclusion Criteria:

* Males and females
* Age 18 - 70 years
* BMI 25 - 38 kg/m-2
* Stable body weight for at least 3 months prior to the study

Exclusion Criteria:

* Concomitant use of any weight loss medication, diet or exercise regime
* Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering medication, diabetes medications
* Previous bariatric or other intestinal surgeries
* Pregnancy or lactation
* Weight loss \> 3 kg within preceding 3 months to enrollment
* Use of bulk laxatives or probiotics/prebiotics supplements
* Antibiotic use in the past month
* Clinically significant cardiovascular or respiratory or liver disease
C: 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
D: Inclusion Criteria:

* Men over the age of 21 years and postmenopausal women with mild-to-moderate hypercholesterolaemia, for whom cholesterol lowering medications are being considered
* Body mass index \<35 kg/m2.
* Treated by diet
* Alcohol intake \< 14 drinks per week.
* Fasting plasma triglyceride (TG) concentration \<4.5 mmol/l.
* Fasting plasma LDL cholesterol concentration \> 4.1 mmol/l at diagnosis or within 30% of their target levels based on risk
* Patients with previous adverse effects on statins (e.g. muscle pains) will also be accepted if the physician responsible for their care considers it appropriate.
* Individuals who prior to cholesterol lowering therapy or after discontinuing cholesterol lowering therapy are within 30% of their treatment LDL-C goals may be permitted to enter the study with the approval of their responsible physician.
* Fit individuals who have had a myocardial infarction or cardiac bypass surgery in the past will not be excluded. Their responsible physician will be asked to provide a letter confirming their suitability for the study.

Exclusion Criteria:

* Premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle.
* Patients will be excluded if they are taking cholesterol medications at the start of the study. However, with their physician's approval, those who wish to join but are already taking cholesterol-lowering medications may join the study providing the medications are stopped for one month before starting the study and throughout the study.
* Patients will be excluded if they are taking cholesterol lowering natural health products such as psyllium, red yeast rice, cholest, polycosanol etc. However, they will be allowed to join the study if they are willing to discontinue these products at least 2 weeks before the start of the study and throughout the study.
* Patients with uncontrolled high blood pressure will be excluded. The cut off for raised blood pressure has been taken as \> 140/90mmHg. Patients with systolic blood pressure between 140-150mmHg and diastolic blood pressure between 90-95mmHg may be accepted, since we have found that on the diet their blood pressures tend to be lowered into the acceptable range. For patients in the above normal range (as above), a letter will be required from the physician responsible for their care. Patients will be excluded if they change the type or dose of their blood pressure treatment during the study.
* Patients will be excluded if they are judged as having a likelihood of being non-compliant with instructions for whatever reason. Those with low compliance to lipid-lowering therapy will not be selected.
* Patients will be excluded if they have evidence or history of diabetes, renal disease, liver disease or gastrointestinal disease. Patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyper-absorbers of plant sterols.
* Individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will be excluded.
* Patients will be excluded from the study if they have a history of any form of cancer apart from non melanoma skin cancer or are considered at high risk for cancer. However, if such patients wish to join the study, we would like them to obtain the approval of their oncologist or responsible physician prior to enrollment in the study. If the study oncologist does not believe it is safe to enroll the participant, the patient will be excluded from the study.

Answer: C