Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001307594
Ethics application status
Approved
Date submitted
24/11/2015
Date registered
30/11/2015
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of aged garlic extract compared to placebo on aerobic fitness and arterial stiffness in sedentary adults
Scientific title
The effect of aged garlic extract compared to placebo on aerobic fitness and arterial stiffness in sedentary adults
Secondary ID [1] 287972 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary 296851 0
elevated pulse wave velocity 296852 0
Condition category
Condition code
Cardiovascular 297083 297083 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 297088 297088 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 297089 297089 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised double-blind placebo-controlled trial of 12 weeks will examine the effect of aged garlic extract on aerobic capacity during moderate intensity exercise, measured by predicted VO2max, and arterial stiffness, indicated by pulse wave velocity and augmentation pressure, in a group of sedentary adults, compared with placebo. The active treatment group will be allocated to two daily capsules of aged garlic extract (1.2 g Kyolic Reserve, 1.2 mg S-allylcysteine (SAC)).

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] 293319 0
Treatment: Other
Comparator / control treatment
The control group will be allocated to two daily capsules of placebo capsules matched in appearance and size to the active treatment capsules. Capsules will be packaged in identical opaque containers including a sachet of activated carbon to eliminate any odour.
Control group
Placebo

Outcomes
Primary outcome [1] 296692 0
Aerobic capacity will be measured by VO2max (mL/kg/min) using the YMCA Submaximal Cycle Ergometer Test. The test is a non-invasive, submaximal exercise protocol in which heart rate-workload points are obtained and extrapolated to age-predicted maximal heart rate of the participant – calculated by subtracting the participant’s age from 220. VO2max is then predicted from the determined maximal workload (the maximal amount of work produced).
The test consists of 3x3-minute stages. The ergometer’s resistance is increased incrementally – each stage selected with respect to the participant’s heart rate in the third minute of each stage.
The first stage will be set at 25 Watts, Stages 2 and 3 are set according to the participant's heart rate in the 3rd or 4th minute of the preceding stage, following the YMCA submaximal cycle test protocol by Nieman D (2010 in Book: Exercise Testing and Prescription. McGraw-Hill Education)
Timepoint [1] 296692 0
8 and 12 weeks compared with baseline
Primary outcome [2] 296693 0
Pulse wave velocity (PWV) and augmentation pressure will be measured before and after each exercise testing session using a Mobil-O-Graph – an electronic blood pressure monitoring system, comprised of an arm cuff and software tool for Pulse Wave Analysis. The device has been shown to be reliable in estimating PWV (Salvade et al., 2015). This is a composite primary outcome.
Timepoint [2] 296693 0
Testing is performed before and after the exercise at 8 and 12 weeks compared to baseline
Secondary outcome [1] 319133 0
Level of exertion by Borg’s Rated Perceived Exertion (RPE) 10-point scale (Borg, 1998)
Timepoint [1] 319133 0
Testing is performed at the end of the third within the fourth minute of each of the 3x3 min stages immediately prior to increasing the workload to the next stage of the exercise test at 8 weeks compared to baseline
Secondary outcome [2] 319134 0
Lactate (hLa) to RPE ratio
Blood samples will be obtained from the right index finger, using an Accu-Chek Safe-T-Pro Plus single use lancing device (www.accu-chek.com.au) and analysed using the Lactate Pro 2 analyser (www.lactatepro.com.au) (Coutts 2007; Miller 2012). hLa:RPE will then be calculated by dividing the blood lactate concentration by the corresponding RPE score, and multiplying it by 100 (Garcin 2002). This ratio will be determined for each of the 3x3 min stages of the exercise test, to ascertain whether supplementation with aged garlic extract has an effect on perceived exertion at a relative intensity, compared with placebo.
Timepoint [2] 319134 0
Testing is performed at the end of the third within the fourth minute of each of the 3x3 min stages immediately prior to increasing the workload to the next stage of the exercise test at 8 and 12 weeks compared to baseline

Eligibility
Key inclusion criteria
1) International physical activity questionnaire (IPAQ) score of 2 or below (minimally active)
2) Elevated pulse wave velocity and / or augmentation pressure (higher half of reference values, adjusted for age and gender) (Nunan 2012; Nunan 2014)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) IPAQ score greater than 3
2) Unstable medical condition or serious illness, at the discretion of their GP (did not pass adult pre-exercise screening tool (AFIRM)
3) Pregnancy
4) Poor comprehension of written or spoken English
5) Currently 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)
Active and placebo capsules will be packaged offsite in identical opaque containers, each containing a sachet with activated carbon to remove the garlic odour.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised to either the intervention (garlic) or control (placebo) group, using a computer-generated permuted block randomisation schedule.
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
A sample size of 80 participants (40 in active / 40 in placebo group) was calculated based on the following assumptions:
a) A significant difference in the change of pulse wave velocity (PWV) of 0.5 m/s with the power of 80% and 95% confidence was found in (Ried 2015), assuming a population mean (SD) of 9. 5 (1.5) m/s.
b) To account for 10% drop-out or non-attendance at all appointments

Statistical significance will be set at p < 0.05. Continuous variables (e.g. age, VO2max) will be compared between groups using Student’s t-test, and categorical variables (e.g. gender, BMI category) by chi-square test.
The difference in means between groups will be compared using Student’s t­-test for normally distributed data (Mann­-Whitney U test for non-normally distributed data) as well as ANCOVA.
Paired t­-test will be used to compare the pre­ and post-­intervention data within groups for normally distributed data (Wilcoxon signed­-rank test for non-­normally distributed data).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/05/2016
Actual
25/02/2017
Date of last participant enrolment
Anticipated
20/12/2020
Actual
26/04/2019
Date of last data collection
Anticipated
Actual
26/04/2019
Sample size
Target
80
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 12275 0
4230 - Robina Town Centre
Recruitment postcode(s) [2] 12276 0
4229 - Bond University

Funding & Sponsors
Funding source category [1] 292445 0
Commercial sector/Industry
Name [1] 292445 0
Wakunaga of America Co Ltd (trial capsules only)
Country [1] 292445 0
United States of America
Funding source category [2] 292462 0
University
Name [2] 292462 0
Bond University
Country [2] 292462 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Institute of Integrative Medicine
Address
21 Burwood Rd, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 291136 0
University
Name [1] 291136 0
Bond University
Address [1] 291136 0
Bond Institute of Health and Sport
2 Promethean Way
Robina QLD 4226
Country [1] 291136 0
Australia
Other collaborator category [1] 278709 0
Individual
Name [1] 278709 0
Prof Liz Isenring
Address [1] 278709 0
Head Masters of Nutrition and Dietetics Practice
Bond Institute of Health and Sport
Bond University
2 Promethean Way
Robina QLD 4226
Country [1] 278709 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293907 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 293907 0
Ethics committee country [1] 293907 0
Australia
Date submitted for ethics approval [1] 293907 0
01/02/2016
Approval date [1] 293907 0
16/02/2016
Ethics approval number [1] 293907 0
0032_2016
Ethics committee name [2] 294456 0
Bond University Human Research Ethics Committee
Ethics committee address [2] 294456 0
Ethics committee country [2] 294456 0
Australia
Date submitted for ethics approval [2] 294456 0
19/02/2016
Approval date [2] 294456 0
Ethics approval number [2] 294456 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61758 0
Dr Karin Ried
Address 61758 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 61758 0
Australia
Phone 61758 0
+61 3 9912 9545
Fax 61758 0
Email 61758 0
[email protected]
Contact person for public queries
Name 61759 0
Karin Ried
Address 61759 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 61759 0
Australia
Phone 61759 0
+61 3 9912 9545
Fax 61759 0
Email 61759 0
[email protected]
Contact person for scientific queries
Name 61760 0
Karin Ried
Address 61760 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 61760 0
Australia
Phone 61760 0
+61 3 9912 9545
Fax 61760 0
Email 61760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.