Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of a Dietary Supplement on Endothelial Function in Volunteers With Light to Moderate Hypertension - a Randomised, Double-blind, Placebo Controlled Cross-over Study
Brief Summary: The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2, R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia are randomly assigned to the dietary supplement or placebo.


Options:
A: Inclusion Criteria:

* History of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
* Stable cardiovascular medication for at least 1 month
* Age ≥ 18 years of age at time of signing the informed consent
* Informed consent for participation in the study

Exclusion Criteria:

* Myocardial infarction, unstable angina, stroke (within 3 months before randomization)
* Thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization)
* Uncontrolled symptomatic congestive heart failure (NHYA\> II) in the last 4 weeks prior to study
* Renal insufficiency (Creatinine Clearance \< 50ml/min)
* Ventricular tachyarrhythmias
* Poorly controlled hypertension, defined as resting blood pressure ≥ 160/100 mmHg
* Symptomatic hypotension
* Obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism and adrenal insufficiency
* Severe uncorrected valvular disease or left ventricular outflow obstruction, which, in the opinion of the investigator, requires surgery
* Long acting nitrates
* Oral or intravenous steroids therapy
* Insulin - dependent diabetes mellitus
* Recipient of any major organ transplant (eg, lung, liver, heart) or renal replacement therapy
* Malignancy (unless healed or remission \> 5 years)
* Anaemia (Hb\< 10g/dl)
* Known to be human immunodeficiency virus (HIV) positive or active virus - hepatitis
* Alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 times the upper limit of the normal range
* Known hypersensitivity to Pycnogenol®
* Alcohol, nicotine abuse or illicit drug abuse
* Pregnancy or breast-feeding, women with child - bearing potential without adequate contraception
* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
* Participation in another study within the last month
B: Inclusion Criteria:

* diabetes mellitus diagnosed at least 5 years
* age greater than or equal to 18 years
* English speaker

Exclusion Criteria:

* proliferative diabetic retinopathy or severe non-proliferative retinopathy
* clinically significant macular edema
* corrected visual acuity less than 20/30 in either eye
* diagnosis of other serious eye disease (glaucoma, age-related maculopathy)
* less than 18 years old
* non-English speaker
* no known allergy or sensitivity to any supplement ingredients
C: Inclusion Criteria:

* borderline blood pressure (systolic 130-149)
* homocystein level \>10µmol/l

Exclusion Criteria:

e.g.

* BMI \<20kg/m2 and \>32kg/m2
* use of antihypertensives, anticoagulants, and statins
* cardiovascular diseases e.g. stroke, myocardial infarction
* use of L-arginine and other dietary supplements
D: Inclusion Criteria:

* Systolic blood pressure between 125 and 159 mmHg and diastolic blood pressure (DBP) \< 100 mmHg
* Body mass index (BMI) 25.0-34.9
* Triglycerides (TG) \< 450 mg/dL
* Low Density Lipoprotein (LDL) \< 200 mg/dL
* Fasting blood glucose (FBG) \< 126 mg/dL

Exclusion Criteria:

* DBP \> 95 mmHg
* LDL \> 170 mg/dL
* TG \> 300 mg/dL
* FBG \> 110 mg/dL

Answer: C