Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled, Parallel Group, Single Blinded, Phase 1 Study That Investigates the Effects of Regular Daily Intake of Small Amounts of Dark or White Chocolate on Blood Pressure in Elderly Individuals With Mild Hypertension
Brief Summary: Regular intake of cocoa-containing foods is linked to a considerably lower cardiovascular and all-cause mortality in observational studies. Short-term intervention studies indicate that high doses of cocoa improve endothelial function and reduce blood pressure (BP), but the clinical impact of long-term intake of small dietary amounts of cocoa on BP and the underlying BP lowering mechanisms are unclear. We hypothesized that cocoa consumption lowers blood pressure by augmentation of the circulating vasodilative nitric oxide (NO) pool due to the action of the cocoa polyphenols at the vascular endothelium.

To test this hypothesis, we will conduct a randomized single-blind, parallel group study in subjects with mild essential hypertension to evaluate the effects of polyphenol-rich dark chocolate versus polyphenol-free white chocolate on blood pressure and plasma levels of cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress. After a 7 day cocoa-free run-in period, 44 subjects will be 1:1 randomized to receive over 18 weeks daily doses of either dark chocolate (6.3 g per day with a total of 30 mg of polyphenols and 30 kcal) or polyphenol free white chocolate (5.6 g per day with 30 kcal, containing similar amounts of macronutrients, electrolytes and vitamins). Subjects will be counseled to maintain an isocaloric diet and to abstain from other cocoa products during the study. Blood pressure and plasma parameters will be assessed in each subject after the run-in period and after 6, 12, and 18 weeks of treatment.


Options:
A: Inclusion Criteria:

* CAD patients over 18 years of age
* Contact university for more details.

Exclusion Criteria:

* Contact university for more details.
B: 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.
C: * INCLUSION CRITERIA

Hypertensive subjects between the ages of 21 - 65 years in good general health except for mild to moderate hypertension (blood pressure between 140/95 and 170/110 off medication), on no medication or nutritional supplements except for antihypertensive agents, anti-cholesterol drugs or birth control agents. Subjects will be taken off all antihypertensive OTC supplements and anti-cholesterol drugs for one week prior to study and for the duration of the study. Women on birth control will remain on their regime. During the time subjects receive no antihypertensive therapy, their blood pressure will be monitored at least daily (either at home, in the clinic, or at another convenient facility). If a subject's blood pressure exceeds 170/110 on three determinations over a period of at least 15 minutes, the subject will be withdrawn from the study and appropriate antihypertensive therapy resumed. In addition, if the subject's blood pressure exceeds 160/100 during measurements on three consecutive days, the subject will be withdrawn from the study and appropriate antihypertensive therapy resumed.

EXCLUSION CRITERIA

Subjects will be excluded if they have diabetes, pregnancy, liver disease, pulmonary disease, renal insufficiency, coronary heart disease, heart failure, peripheral vascular disease, coagulopathy, actively smoked tobacco within last two years, in treatment for any form of cancer, positive tests for HIV, hepatitis B or C, or take systemic corticosteroids. These conditions are all known to adversely influence insulin sensitivity.

Subjects will be excluded if they have a history of malignant hypertension, aortic aneurysm or stroke.

Subjects with known hypersensitivity to octafluoropropane or with known cardiac shunts will also be excluded from participating because of potential adverse effects from microbubble contrast agent.

Subjects will be excluded if they are unable to give informed consent for all procedures.

Children are excluded from this study because children are not typically hypertensive.
D: 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

Answer: B