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

Phase 3

Completed

• Conditions: Hypertension; Cardiovascular function; Cardiovascular - Hypertension

• Registration Number: ACTRN12613000747729
• Lead Sponsor: ational Institute of Integrative Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

- Poor comprehension of written or spoken English
- Unstable other medical conditions or serious illness, at the discretion of the GP, e.g. dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis, and pregnancy
- Severe hypertension (mean sitting SBP>=180 mm Hg and DBP >=100 mm Hg) at enrolment or subsequent visits during the study. Patients with severe hypertension will be referred back to their GP for further management
- Already taking daily garlic supplements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical blood pressure (Systolic and diastolic, SBP/DBP):<br>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.[12 weeks compared with baseline]

Secondary Outcome Measures

Name	Time	Method
Haemodynamic parameters: <br>Central blood pressure, pulse wave velocity, arterial stiffness using the Mobilograph device<br>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.[12 weeks compared with baseline];Cardiovascular biomarkers: <br>Blood lipids, platelet function, homocysteine, inflammatory markers.[12 weeks compared to baseline]