Aged Garlic Extract for heart health: A 3-month randomised placebo-controlled trial

INTERVENTION: The active treatment group will be allocated to two capsules of aged garlic extract (AGE, Kyolic, 480 mg, 1.2 mg SAC (2 capsules x 240 mg/0.6 SAC) daily for 3 months. The control group will be allocated to matching placebo capsules. AGE is highly tolerable, and was acceptable for 92% of patients in previous trials. Participants are advised to take AGE in the evening with food to minimise belching. Compliance will be assessed by return of trial capsules, as well as diary entries. Patients will be instructed to mark each day in provided calendars when they have taken the trial and prescription medications, and bring the calendar and the remaining trial medication to their next appointment. CONDITION: Cardiovascular function Hypertension PRIMARY OUTCOME: Clinical blood pressure (Systolic and diastolic, SBP/DBP): ; A trained research assistant/nurse will use a validated digital sphygmomanometer with appropriate sized cuffs (Omron HEM‐907, JA Davey Pty Ltd; calibrated against a mercury sphygmomanometer). The display of the sphygmomanometer is to be positioned away from the patient to assure blinding to the BP readings. BP measurement to be taken with patient in seated position with arm supported at heart level, after 5 min rest, after abstinence from food, nutritional supplements, caffeinated beverages, and smoking for a minimum of 2 hours prior to BP measurement at approximately the same time/day of the week. BP will be recorded as three serial measurements at intervals of 30 seconds. The mean of the three BP measurements will be used in the analysis. SECONDARY OUTCOME: Cardiovascular biomarkers: ; Blood lipids, platelet function, homocysteine, inflammatory markers. Haemodynamic parameters: ; Central blood pressure, pulse wave velocity, arterial stiffness using the Mobilograph device ; The Mobilograph is a brachial non‐invasive device which takes a 10 second snapshot of the radial arterial pressure wave and derives the ascending aortic pressure wave, providing critical cardiovascular measurements including central blood pressure, aortic augmentation index, ejection duration and subendocardial viability ratio. INCLUSION CRITERIA: ‐ Essential hypertension: Mean diastolic blood pressure >=90 mm Hg and systolic SBP >=140 mm Hg to be confirmed under trial conditions at the screening appointment (at screening mean DBP of >=88 / SBP >=135 mm Hg will be included) ‐ Either not on blood pressure medication, or on established plan of blood pressure medication (one or more classes) for at least 2 months ‐ The patient’s family doctor /general practitioner (GP) is not planning to change current treatment during the 3 month trial ‐ Able to give informed consent