Please select the eligibility criteria that correspond to the clinical trial below.
Title: Macronutrient Composition of Diet and Risk Factors for Cardiovascular Disease
Brief Summary: The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults.

The investigators will test the following hypotheses:

Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in carbohydrates will reduce body weight, total percent body fat, and waist circumference over 12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce serum levels of LDL-cholesterol and triglycerides and increase serum levels of HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.


Options:
A: Inclusion Criteria:

* BMI\>27
* age\>40
* History of CHD or diabetes in any age or BMI level

Exclusion Criteria:

* Pregnant or lactating women.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serum creatinine \> 3 mg/dl.
* Liver dysfunction ( ³ 2 fold level of ALT and AST enzymes).
* Participation in another trial in which active intervention is being received.
* Any intestinal problem that would prevent the patient from eating one of the test diets (for example, gastric stapling that might prevent consumption of vegetables).
B: Inclusion Criteria:

* Men or women aged 22 - 75 years, any race/ethnicity
* BMI of 30 - 45 k/m2
* Willing and able to provide informed consent

Exclusion Criteria:

* History of self-reported clinical CVD (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
* Medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
* Current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
* For women, current pregnancy or breastfeeding or plans to become pregnant during the study period
* Consumption of more than 21 alcoholic beverages per week
* Currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss \>15 pounds within 6 months of study entry
* Plans to move out of the study area (\>1 hour from study site) or difficulty to come to the study site
* Participation of another household member in the study; employees or persons living with employees of the study
* Participation in other lifestyle intervention trials currently
* At the discretion of the study coordinator
C: Inclusion Criteria:

* Age: 16-35 years
* Body mass index (kg/m2): 28-36

Exclusion Criteria:

* Body weight fluctuations \> 3 kg over the previous 2 months
* Smoking

Presence of:

* Cardiovascular diseases, cancer tumours, kidney or lever diseases, infections or endocrinological diseases, malabsorption disorders
* Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg
* Hypercholesterolemia with changes in pharmacological treatment within the last 2 months
* Regular use of medicine other than birth pills, any psychological disorders, known or presumed abuse of alcohol, allergies to any food, special diets (eg. vegetarian) or particular dislikes
* Pregnancy, lactating or planning pregnancy within 18 month from enrolment
D: Inclusion Criteria:

* Pregnant women from families with at least one family member having an allergic disease

Exclusion Criteria:

* Women presenting severe immunological or other chronic diseases (rheumatoid arthritis, diabetes, inflammatory bowel disease, thyroid diseases, malignancies etc.)
* Women who cannot be expected to comply with treatment
* Women currently participating or having participated in other clinical trial during the last 2 months prior to the beginning of the intervention.

Answer: B