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Trial registered on ANZCTR
Registration number
ACTRN12620000340932
Ethics application status
Approved
Date submitted
25/02/2020
Date registered
11/03/2020
Date last updated
5/10/2021
Date data sharing statement initially provided
11/03/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of Kyolic garlic on aerobic fitness in middle aged recreational endurance athletes: The Kyolic garlic & aerobic fitness trial
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Scientific title
The effect of Kyolic aged garlic extract on arterial stiffness and aerobic fitness in middle-aged recreational endurance athletes: A randomized double-blind placebo-controlled dose-response trial of 12 weeks duration
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Secondary ID [1]
300651
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aerobic fitness
316439
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Arterial Stiffness
316440
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Condition category
Condition code
Cardiovascular
314693
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0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Double-blind parallel randomised placebo-controlled dose-response trial of 12 weeks duration investigating the effect of two (participant ID 1-40) or four (ID 41-80) capsules of aged garlic extract (AGE) (Kyolic Reserve Formula containing 1.2g/2.4g AGE powder, 1.2mg/2.4mg SAC (2 or 4 capsules x 600 mg/0.6 mg SAC) on arterial stiffness and aerobic fitness during high intensity exercise in a group of middle-aged recreational endurance athletes.
The first half of participants will be allocated to 2 capsules daily (ID 1-40), the second half of participants (ID 41-80) will be allocated to 4 capsules daily.
Compliance will be monitored by return of remaining investigational product/ trial capsules at 4-weekly intervals.
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Intervention code [1]
316982
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Treatment: Other
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Comparator / control treatment
The control group will be allocated to matching number placebo capsules containing microcrystalline cellulose.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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VO2 max by Cycle ergometer test station via metabolic cart.
Cycling maximal oxygen consumption is collected during incremental exercise workloads to exhaustion. Bike protocol: 0-3 min, the subject pedals at a rate of 60 rpm with 0 kp resistance. After 3 minutes, the workload is increased by 0.5 kp (30 Watts) every 3 min until exhaustion.
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Assessment method [1]
323032
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Timepoint [1]
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12 weeks compared to baseline
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Primary outcome [2]
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Pulse wave velocity = arterial stiffness by sphygmomanometer (Atcor SphygmoCor)
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Assessment method [2]
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Timepoint [2]
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12 weeks compared to baseline
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Secondary outcome [1]
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Lactate threshold by lactate test strip by finger prick during cycle ergometer VO2 max testing;
One finger prick required, blood taken from the same spot every 3 minutes at the same time as incremental workload is increased
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Assessment method [1]
380549
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Timepoint [1]
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12 weeks compared to baseline
One finger prick required, blood taken from the same spot every 3 minutes at the same time as incremental workload is increased
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Secondary outcome [2]
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Composite measure: Fatigue, muscle soreness, recovery by validated questionnaire (Descriptor differential scale)
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Assessment method [2]
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Timepoint [2]
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12 weeks compared to baseline
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Secondary outcome [3]
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Subgroup: proteomic biomarkers - cardiovascular polypeptide panel of 25 urinary polypeptide markers (Brown et al Proteomic Clin Appl 2015; 9 (5-6_:610-7).
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Assessment method [3]
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Timepoint [3]
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12 weeks compared to baseline
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Eligibility
Key inclusion criteria
1) Elevated pulse wave velocity/arterial stiffness (>10% than average of reference values adjusted for age and gender)
2) Minimum exercise 3x30min/wk moderate to high intensity (E.g. triathletes, swimming, running, cycling)
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Minimum age
40
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unstable other medical conditions or serious illness, e.g. CAD, dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis, and pregnancy
- Already taking daily garlic supplements
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Active and placebo capsules, matched in number, colour and appearance, will be packaged offsite in visually identical numbered opaque containers.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization using a computerized random number generator by an independent researcher off-site.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
Dose-response
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size
A sample size of 80 participants (n=40 in active group and n=40 in placebo group; including lower dose group ID 1-40: n=20 in active/ n=20 in placebo group; higher dose group ID41-80: n=20 in active/ n=20 in placebo group) was calculated based on the following assumptions:
a) To detect a difference of 8% (SD=12) change in the age-adjusted PWV (mean=72%) at 12 weeks compared to baseline (mean=64%)
b) To account for 10% drop-out or non-attendance at all appointments
Subgroup n=60 – Cardiovascular proteomic biomarkers
Sample size
A sample size of 60 participants (30 in each group) was calculated based on the following assumptions:
a) To detect a difference of 0.3 (SD=0.4) change in the CAD proteomic score (mean=0.5) at 12 weeks compared to baseline (mean=0.8)
b) To account for 10% drop-out or non-attendance at all appointments
Analysis
Analyses will be performed using SPSS (PASW version 18). Statistical significance will be set at p<0.05. Differences within-groups and between-groups at baseline and at 3 months will be assessed by chi-square test for binominal variables, by Kruskal-Wallis test for ordinal variables, and by one-way ANCOVA with Bonferroni adjustment and post-hoc Dunnett’s test for continuous variables.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/04/2020
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Actual
1/10/2020
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Date of last participant enrolment
Anticipated
1/12/2021
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Actual
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Date of last data collection
Anticipated
1/06/2022
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Actual
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Sample size
Target
80
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Accrual to date
40
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
29485
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3122 - Hawthorn
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Recruitment postcode(s) [2]
29486
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3144 - Malvern
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Recruitment postcode(s) [3]
29487
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3000 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Wakunaga of America Co Ltd
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Address [1]
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23501 Madero
Mission Viejo
California 92691
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Country [1]
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United States of America
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Primary sponsor type
Individual
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Name
AProf Dr Karin Ried
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Address
National Institute of Integrative Medicine (NIIM)
21 Burwood Rd
Hawthorn, VIC 3122
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
305445
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Country [1]
305445
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305466
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National Institute of Integrative Medicine Human Research Ethics Committee
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Ethics committee address [1]
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National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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25/02/2020
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Approval date [1]
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28/07/2020
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Ethics approval number [1]
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0062N_2020
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Summary
Brief summary
Arterial stiffness is a cardiovascular risk factor, which increases naturally with age. We and others have shown, that Kyolic garlic reduces arterial stiffness by improving the flexibility of arteries. We hypothesise that increased flexibility of arteries will lead to slower blood flow, increased oxygen uptake, and aerobic fitness.
This 12 week RCT aims to assess the effect and dose-response of Kyolic garlic on arterial stiffness, lactate threshold, aerobic fitness, recovery, and cardiovascular proteomic biomarkers, in middle-aged endurance athletes with elevated arterial stiffness.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Karin Ried
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Address
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National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
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Country
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Australia
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Phone
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+61 3 9912 9545
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Karin Ried
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Address
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National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
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Country
100467
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Australia
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Phone
100467
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+61 3 9912 9545
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Fax
100467
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Email
100467
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[email protected]
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Contact person for scientific queries
Name
100468
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A/Prof Karin Ried
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Address
100468
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National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
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Country
100468
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Australia
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Phone
100468
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+61 3 9912 9545
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Fax
100468
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Email
100468
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Summary data will be made available for publication. No individual data will be divulged.
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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.
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