Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of the Practical Application, Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol
Brief Summary: The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors. If potent lipid-lowering effects through novel dietary interventions can be demonstrated, then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease.

Aims:

* To determine the percentage of lipid clinic attendees interested in making a serious dietary change.
* To determine the extent to which a self selected dietary portfolio combining viscous fiber foods (oat \& barley β-glucan, psyllium, etc.), soy and vegetable protein foods (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice.
* To determine whether this effect can be maximized by more frequent follow-up, and what, if any, would be the relationship between dietary compliance and reduction in LDL-C.


Options:
A: 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.
B: Inclusion Criteria:

* Female.
* Age 21 years or greater. Both pre- and postmenopausal women will be included in this study. Postmenopausal status will be defined as the absence of menses for \> 12 months, serum follicle stimulating hormone (FSH)\> 20 milli-international units per milliliter (mIU/ml), or history of bilateral oophorectomy.
* Hispanic descent and fluent in Spanish.
* History of histologically-confirmed stage 0, I, II, or III invasive breast carcinoma without evidence of disease recurrent or metastatic disease at trial entry.
* Minimum of 3 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery. Current use of hormonal therapy is permitted.
* No uncontrolled diabetes mellitus, defined as Hgb A1C \>7.
* No uncontrolled comorbidities (i.e., hypertension).
* Currently a non-smoker (rationale: women who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for these women to stop smoking than it is to change their dietary patterns).
* Consumes \<5 servings of fruits and vegetables per day, as assessed by the Block Fruit and Vegetable Screener.
* In the pre-contemplation, contemplation, or preparation stage of increasing daily fruit and vegetable intake.
* Access to functional home phone or cell phone.
* Willing and able to participate in all study related activities, including study clinic visits, phone interviews, and nutrition counseling sessions.
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Evidence of recurrent or metastatic breast cancer.
* Uncontrolled diabetes (type 1 or 2), defined as Hemoglobin (Hgb) A1C \>7.
* Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; active malignancy, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements.
* Previously participated in Cook For Your Life! classes.
* Currently active in a dietary change program.
C: Inclusion Criteria: Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria), 18 ≤BMI ≤ 25

Exclusion Criteria: Age \<18 or \>35 years, BMI less than 18 and higher than 25, Pregnancy, Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months, neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea).

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D: Inclusion Criteria:

* American Spinal Injury Association classification A, B, C as long as they are not functional ambulators

Exclusion Criteria:

* Stage III or IV pressure ulcers, pregnancy, end-stage renal disease, treatment for cancer except for nonmelanoma skin cancer within the past five years, and chronic, nontobacco substance-abuse, cognitive impairment with inability to learn

Answer: A