Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of the Effect of Ready-cooked Meals Containing Cocoa Extract, as a Potential Functional Ingredient, on Cardiovascular Risk Markers in Older Population
Brief Summary: Obesity prevalence in elderly populations has increased in the last years, and the reduction of overweight and obesity is a priority target in populations of all age ranges worldwide. Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic functions may be compromised, and therefore there is a risk of developing comorbidities such as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context, plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols have been shown to have an important antioxidant effect. Scientific evidence based on epidemiological studies suggest that flavonoids from the diet play an important role on the prevention of cardiovascular disease. Cocoa and related products are an important source of flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa consumption are related to the ability for improving lipid profile and insulin sensitivity, reducing blood pressure, platelet activity and improving endothelial dysfunction. Some studies have also shown an improvement of inflammatory conditions, mainly due to the capacity of the polyphenols contained to modify cellular transcription, and the secretion of proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic strains. Therefore, the hypothesis of this study is that the consumption of cocoa extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight and to improve cardiovascular risk factors compared to the same diet with standard prepared meals.


Options:
A: Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.

At least 3 of following 5 criteria must be present:

1. waist circumference \> 88 cm
2. Triglycerides \> 150 mg/dl
3. HDL-cholesterol \< 50 mg/dl
4. Fast glycemia \> 110 mg/dl
5. Systolic blood pressure \> 135 mmHg. diastolic \> 85 mmHg -

Exclusion Criteria:

1. post-menopausal women with less than 12 months from the last menstruation
2. less than 3 criteria according with ATP III
3. TSH \> 3.5
4. in treatment with drugs lowering glycemia or cholesterol
5. allergy to cocoa
B: Inclusion Criteria:

* Body Mass Index between 27 and 35.5 kg/m2
* Subjects with central adiposity (waist circumference over 94 cm in males and 80 cm in females)
* Subjects presenting insulin resistance non pharmacologically treated
* Subjects presenting hyperlipidemia non pharmacologically treated

Exclusion Criteria:

* Subjects following dietotherapy to loose weight at the moment of the study or in the past three months.
* Subjects with variations of weight greater than 5% of their body weight in the last three months).
* Subjects with deficient nutritional or hydration status.
* Subjects suffering from chronic diseases such as cancer, diabetes, hyperlipidemia, etc.
* Subjects with functional or structural impairments in digestive tract (peptic ulcer, malabsorption syndrome, inflammatory state, etc.)
* Subjects having gone under digestive surgery and have permanent consequences.
* Subjects suffering from allergy to cocoa or derived products.
* Subjects being physically or psychologically affected, with difficulties to attend the facilities with the required frequency.
* Smokers and frequent (more than 3 portions of beer/wine/spirits per day in males and 2 portions of beer/wine/spirits per day in females)
C: 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
D: * 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.

Answer: B