Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial
Brief Summary: Previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. Research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark chocolate. The investigators now wish to test if consuming fruits and vegetables (including berries which are very rich in polyphenols), as well as dark chocolate, has further benefits for cardiovascular function. A total of 110 subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a washout period). They will then be randomised to continue this diet or to consume 6 portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and delivered to the homes of the participants who are randomised to the high fruit and vegetable arm of the study.

Assessment of microvascular and platelet function will be undertaken before and after consuming this diet. Improvements in these tests of cardiovascular function have previously been linked to reduced risks of heart disease in people with high blood pressure. This study will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of developing heart disease.


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:

* Young adults.
* Aged between 20 and 40 years.
* Both sexes.
* Those agree to sign the informed consent.

Exclusion Criteria:

* History of cardiovascular events (acute myocardial infarction, stroke, etc.).
* History of hypertension, diabetes mellitus or dyslipidemia.
* Pharmacological treatment for any of the above conditions.
* Diagnosis of clinically demonstrable neurological and/or neuropsychological disease.
* Excessive consumption of toxic substances.
* Celiac patients and/or those intolerant to lactose.
* Subjects on a low-calorie and/or low-sodium diet.
* Pregnant women.
* Those with any other circumstance that the investigators consider could interfere with the study procedures.
C: 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
D: Inclusion Criteria:

* male, age 35-60 years, healthy
* female, age 35-60 years, healthy

Exclusion Criteria:

* diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)

Answer: C