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:

* Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

* hemoglobin A1c values \<6.5% or \>10.5%
* use of insulin for \> 5 years
* tobacco use within the preceding 6 months
* consumption of more than 2 alcoholic beverages per day
* current drug abuse
* pregnancy
* unstable medical status
* current use of a low-fat, vegetarian diet.
B: Inclusion Criteria:

* Only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area
* Between the ages of 30 - 70
* Willing to modify eating pattern according to instructions
* Overweight or obese and in good health with a BMI of 25-40
* Committed to a long-term weight loss and maintenance program
* Willing to attend multiple weight loss group sessions
* Willing to increase activity level

Exclusion Criteria:

* Pregnant, planning to become pregnant, or are breastfeeding
* Unwilling to participate in the schedule of group sessions and individual visits
* Unstable or recent onset of heart disease or any other serious illness
* Cannot change diet due to medical or other reasons
* Planning to leave the area prior to the anticipated end of participation
* Current participation in another clinical trial with an intervention that affects weight change
* Have diabetes that is treated with insulin or hypoglycemic oral medicines
* Diagnosis of psychiatric or emotional problems within 6 months of study
* Currently have an eating disorder
* Have hypothyroidism
* Have an unstable weight
C: Inclusion Criteria:

* Men or women age 30-65,
* BMI in the range 28-35 kg/m2 for women and 28-40kg/m2 for men.
* At least one of the following components of the metabolic syndrome; fasting triglycerides \> 1,7, fasting glucose 6,0-6,9, HDL-cholesterol \<1,03 (males) or \<1,29 (females), Blood pressure \>130/85 (with or without treatment), diet-treated diabetes mellitus or drug treated hypertension.
* Stable weight range of 4 kg or less the last 12 weeks,
* No major change in physical activity the last 12 weeks

Exclusion Criteria:

* Any symptomatic cardiovascular disease
* Diabetes requiring drug treatment
* Currently on special diet
* Hepatic/renal dysfunction
* Hypothyroidism (unstable)
* GI disorder impairing compliance with diet recommendation,
* History of unstable psychiatric or medical disorder,
* Need of lipid lowering drug,
* Alcohol or drug abuse,
* Participation in drug trial the last 30 days,
* Use of drugs for weight reduction last 12 weeks, pregnancy or planned pregnancy,
* Obesity of known endocrine origin, history of obesity surgery,
* Uncontrolled hypertension (\>160/100),
* Previous participation in \>3 weight reduction programs, or within last 12 months,
* Not willing to be randomized,
* Individual judged to be unable to follow instructions and procedures of the study
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: D