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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
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
Secondary ID [1] 300651 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aerobic fitness 316439 0
Arterial Stiffness 316440 0
Condition category
Condition code
Cardiovascular 314693 314693 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 316982 0
Treatment: Other
Comparator / control treatment
The control group will be allocated to matching number placebo capsules containing microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 323032 0
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.
Timepoint [1] 323032 0
12 weeks compared to baseline
Primary outcome [2] 323033 0
Pulse wave velocity = arterial stiffness by sphygmomanometer (Atcor SphygmoCor)
Timepoint [2] 323033 0
12 weeks compared to baseline
Secondary outcome [1] 380549 0
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
Timepoint [1] 380549 0
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
Secondary outcome [2] 380550 0
Composite measure: Fatigue, muscle soreness, recovery by validated questionnaire (Descriptor differential scale)
Timepoint [2] 380550 0
12 weeks compared to baseline
Secondary outcome [3] 380551 0
Subgroup: proteomic biomarkers - cardiovascular polypeptide panel of 25 urinary polypeptide markers (Brown et al Proteomic Clin Appl 2015; 9 (5-6_:610-7).
Timepoint [3] 380551 0
12 weeks compared to baseline

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)
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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, matched in number, colour and appearance, will be packaged offsite in visually identical numbered opaque containers.
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.
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
Dose-response
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
1/10/2020
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
80
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 29485 0
3122 - Hawthorn
Recruitment postcode(s) [2] 29486 0
3144 - Malvern
Recruitment postcode(s) [3] 29487 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 305075 0
Commercial sector/Industry
Name [1] 305075 0
Wakunaga of America Co Ltd
Country [1] 305075 0
United States of America
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine (NIIM)
21 Burwood Rd
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 305445 0
None
Name [1] 305445 0
Address [1] 305445 0
Country [1] 305445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305466 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 305466 0
Ethics committee country [1] 305466 0
Australia
Date submitted for ethics approval [1] 305466 0
25/02/2020
Approval date [1] 305466 0
28/07/2020
Ethics approval number [1] 305466 0
0062N_2020

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

Contacts
Principal investigator
Name 100466 0
A/Prof Karin Ried
Address 100466 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 100466 0
Australia
Phone 100466 0
+61 3 9912 9545
Fax 100466 0
Email 100466 0
karinried@niim.com.au
Contact person for public queries
Name 100467 0
Karin Ried
Address 100467 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 100467 0
Australia
Phone 100467 0
+61 3 9912 9545
Fax 100467 0
Email 100467 0
karinried@niim.com.au
Contact person for scientific queries
Name 100468 0
Karin Ried
Address 100468 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 100468 0
Australia
Phone 100468 0
+61 3 9912 9545
Fax 100468 0
Email 100468 0
karinried@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summary data will be made available for publication. No individual data will be divulged.


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.