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Trial registered on ANZCTR


Registration number
ACTRN12613000747729
Ethics application status
Approved
Date submitted
3/07/2013
Date registered
4/07/2013
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Aged Garlic Extract for heart health: A 3-month randomised placebo-controlled trial
Scientific title
The effect of aged garlic extract on blood pressure and other cardiovascular risk factors in adults with uncontrolled hypertension: A 3-month randomised double-blind placebo-controlled trial
Secondary ID [1] 282784 0
Nil
Universal Trial Number (UTN)
Trial acronym
AGE at Heart trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 289548 0
Cardiovascular function 289549 0
Condition category
Condition code
Cardiovascular 289873 289873 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287460 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules
Control group
Placebo

Outcomes
Primary outcome [1] 289936 0
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.
Timepoint [1] 289936 0
12 weeks compared with baseline
Secondary outcome [1] 303605 0
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.
Timepoint [1] 303605 0
12 weeks compared with baseline
Secondary outcome [2] 303606 0
Cardiovascular biomarkers:
Blood lipids, platelet function, homocysteine, inflammatory markers.
Timepoint [2] 303606 0
12 weeks compared to baseline

Eligibility
Key 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
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited through general practices, and search of electronic clinical records for hypertension.

Consenting and eligible participants will be enrolled at the study site and allocated randomly to either the active or the placebo group. Garlic and placebo capsules are matched in appearance and are packaged in identical containers labelled with the ID and trial name.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated permuted block randomisation schedule will be used to allocate patients to garlic or placebo groups within each recruitment site. Randomisation will be done by a statistical consultant not involved in allocation of treatment to the participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A sample size of 100 patients was calculated based on the following assumptions:
a) To detect a difference of 10 mmHg SBP (SD=10) or 6.5 mmHg DBP (SD=11) in BP change between the active treatment (n=50) and control groups (n=50) with a power of 80% and 95% confidence; b) to account for 10% drop-out or non-attendance at all appointments; c) to adjust for clustering using a design effect of 1.2 based on the formula: Design effect = [1+ (size of cluster-1) x intracluster correlation coefficient of 0.02].
1630 patients from about 8 general practices will be invited, assuming a 15% response rate, 40% have diastolic hypertension under trial conditions, and each practice providing access to 160 patients. Proportions are estimated based our previous studies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7064 0
3123 - Hawthorn East
Recruitment postcode(s) [2] 7065 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 287556 0
Commercial sector/Industry
Name [1] 287556 0
Wakunaga of America Co Ltd
Address [1] 287556 0
23501 Madero
Mission Viejo
CA 92691
Country [1] 287556 0
United States of America
Primary sponsor type
Other
Name
National Institute of Integrative Medicine
Address
759 Burwood Rd
Hawthorn East, VIC 3123
Country
Australia
Secondary sponsor category [1] 286307 0
None
Name [1] 286307 0
Address [1] 286307 0
Country [1] 286307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289533 0
NIIM Human Research Ethics Committee
Ethics committee address [1] 289533 0
759 Burwood Rd
Hawthorn East, VIC 3123
Ethics committee country [1] 289533 0
Australia
Date submitted for ethics approval [1] 289533 0
20/06/2013
Approval date [1] 289533 0
18/07/2013
Ethics approval number [1] 289533 0
252

Summary
Brief summary
Our 3-month randomised placebo controlled double-blind trial study aims to investigate the effect of aged garlic extract on blood pressure and other cardiovascular biomarkers including cholesterol, homocysteine and arterial stiffness in a group of adults with uncontrolled hypertension.
Trial website
Trial related presentations / publications
Ried K, Travica N, Sali A. The effect of aged garlic extract on blood pressure and other cardiovascular risk factors in uncontrolled hypertensives: the AGE at Heart trial. Integrative Blood Pressure Control 2016: 9, 9-21
Public notes

Contacts
Principal investigator
Name 41230 0
Dr Karin Ried
Address 41230 0
National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East
VIC 3123
Country 41230 0
Australia
Phone 41230 0
+613 9804 0646
Fax 41230 0
Email 41230 0
karinried@niim.com.au
Contact person for public queries
Name 41231 0
Dr Karin Ried
Address 41231 0
National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East
VIC 3123
Country 41231 0
Australia
Phone 41231 0
+613 9804 0646
Fax 41231 0
Email 41231 0
karinried@niim.com.au
Contact person for scientific queries
Name 41232 0
Dr Karin Ried
Address 41232 0
National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East
VIC 3123
Country 41232 0
Australia
Phone 41232 0
+613 9804 0646
Fax 41232 0
Email 41232 0
karinried@niim.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary