Please select the eligibility criteria that correspond to the clinical trial below.
Title: Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
Brief Summary: The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.


Options:
A: Inclusion Criteria

* Female
* Having had a natural menopause and a minimum of 1 year since last menstruation
* Caucasian
* under 70 years
* Type 2 diabetics
* Those using statins (≥40 mg simvastatin or ≥10 mg atorvastatin) for at least 12 months
* Not currently taking Hormone Replacement Therapy (HRT) and not having taken HRT for a minimum of 6 months prior to commencement
* Having no significant past or present medical history of vascular disease, or cancers (specifically breast, uterine or ovarian)
* Never-smokers, and ex-smokers who have given up smoking at least 12 months before recruitment to the study

Exclusion Criteria

* Currently taking HRT or having taken this medication within 6 months of the trial
* Those prescribed to use statin therapy for less than 12 months Significant past or present medical history of vascular disease (including ECG and enzyme confirmed myocardial infarction, clinical angina, ischaemic stroke peripheral vascular disease, intermittent claudication) or cancer (especially breast, uterine or ovarian)
* Hypertensive's with a systolic BP ≥ 160 mm Hg at maximum, or hypertensive's with a systolic BP ≤160 mm Hg at maximum, but who have received antihypertensive therapy for less than 12 months or have had increases to their medication indicating poor control
* Current smokers or those having given up smoking less than 12 months before recruitment to the study
* Those prescribed aspirin for a period of less than 12 months prior to recruitment
* Those prescribed insulin for a period of less than 12 months prior to recruitment and those having had increases to their medication indicating poor control
* Regular non-prescribed use of anti-inflammatory pain relief medication (i.e. aspirin, paracetamol, cocodamol).
* Taking other counter indicative medication e.g. steroidal medication during the trial, or within 1 month of the trial beginning.
* Taking food / dietary supplements e.g. vitamins, minerals, fish oils, plant oils, isoflavones, soy products, carotenoids during the trial (unless prepared to cease intake during, and 1 month preceding the trial).
* Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
* Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/material
* Assessed from the clinical screening: HbA1c ≥ 10%; Creatinine \>125µmol/L; ALP \> 378 IU/L; ALT \>150 IU/L; GGT \> 180 IU/L
B: Inclusion Criteria:

* Age 40-65 years old
* Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-109 mmHg

Exclusion Criteria:

* diabetes mellitus
* an acute coronary syndrome or transient ischaemic attack within the past 3 months
* special dietary requirements, food sensitivities or vegetarian/vegan diet by choice
* oral anticoagulation therapy
* body mass index greater than 35kg/m2
* excessive alcohol consumption (defined as \> 28 units/week in men and 21 units/week in women)
* fasting triglyceride concentration \> 4 mmol/l
* pregnancy/lactation
* taking antioxidant supplements
* medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
C: Inclusion Criteria:

* Subjects between the ages of 55 - 75 years in good general health with high normal blood pressure (between 130/80 and 140/90 mmHg) or mild hypertension (blood pressure between 140/90 and 160/100 mmHg)on no medication or nutritional supplements
* Non-manual workers with a household income \> 20,000 €/year
* Normal plasma lipids (total plasma cholesterol \< 6.18 mmol/L
* LDL \< 4.11 mmol/L
* HDL \> 0.9 mmol/L
* Triacylglycerols \< 1.8 mmol/L) and normal plasma glucose (fasting plasma glucose 4.2-6.4 mmol/L).
* If a subject's blood pressure exceeds 170/100 mmHg on a single visit, the subject will be withdrawn from the study and referred to appropriate antihypertensive therapy.

Exclusion Criteria:

Subjects are excluded if they have:

* Cardiovascular diseases (other than hypertension)
* Diabetes mellitus
* Hyper-/dyslipidemia
* Gastrointestinal diseases
* Hepatic and renal disorders
* Pulmonary diseases
* Coagulopathy
* Cancer
* Psychiatric disorders
* Alcohol or drug dependence
* Seizure disorders
* History of organ transplantation
* Surgery within the last 12 months
* Positive tests for HIV, hepatitis B or C.

Subjects are excluded if they have:

* A body-mass index of more than 27.5 or less than 18.5 kg/m2
* Actively smoked tobacco within the last five years
* Regularly use medications
* Used any medication within the last two weeks before entry
* Use vitamin, mineral or polyphenol supplements or functional food.

Subjects will be excluded if they are unable to give informed consent for all procedures; or subjects who are not capable or willing to appear for controlling visits.
D: Inclusion Criteria:

* Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
* Willing and able to participate in the study protocol
* Written informed consent
* Age 40-70 years
* 10-year risk of developing CHD \<10%, based on data from the Framingham Heart Study
* BMI \> 18 and \< 30 kg/m2
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician
* Willing to comply with the dietary restrictions of the study.
* Accessible veins on arm(s) as determined by examination at screening

Exclusion Criteria:

* Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
* Diabetes mellitus
* Reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male)
* Currently on a medically prescribed diet, or slimming diet
* Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
* Reported intense sporting activities \> 10 h/w
* Use of prescribed medication which may interfere with study measurements, as judged by the physician
* Use of antibiotics in the three months before screening or during the study.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
* Reported intolerance to test products or other food products provided during the study
* Blood donation 1 month (males) or 2 months (females) prior to screening and during the study
* Reported participation in another nutritional or biomedical trial 3 months before screening or during the study.
* Extreme coffee consumption

Answer: A