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:

* Established diagnosis of type 2 diabetes
* Male or female alcohol abstainers (not more than 1 drink/week)
* Age between 40-75 yrs
* Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months

Exclusion Criteria:

* The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion
* Triglycerides \> 500 mg/dL
* HbA1c\<7 or \> 10%
* Serum creatinine \> 2 mg/dl
* Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST)
* Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy)
* Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness
* Patients with chronic hepatitis (C,B)
* Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants
* Presence of active cancer, or chemotherapy within the past 3 years
* Major illness that may require hospitalization
* A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse
* Pregnant or lactating woman
* Participation in another trial with active intervention
B: Inclusion Criteria:

* In- and outpatients of the Neurology Department of the CHL and their family members
* Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction
* No acute stroke/TIA/amaurosis fugax (at least 3 months ago)
* Temporal ultrasound window suitable for recording of the middle cerebral artery
* Ability to give informed consent

Exclusion Criteria:

* No signed informed consent
* patient not able to give informed consent
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:

1. Age between 40-75 yrs.
2. Alcohol abstainers (less than or equal to 1 drink/week)
3. Established diagnosis of type 2 diabetes.
4. Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.

Exclusion Criteria:

1. Taking Insulin \>2 injections /day, or with insulin pump.
2. TGs\>500 mg/dL.
3. HbA1c \>10%
4. Serum creatinine \> 2 mg/dl
5. Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)

5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).

6. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.

9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).

10. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.

11. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.

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Answer: C