Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000576921
Ethics application status
Approved
Date submitted
3/06/2011
Date registered
3/06/2011
Date last updated
7/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chilli versus aspirin: effect on platelet aggregation and vascular function.
Scientific title
Chilli versus aspirin - effect on platelet aggregation and vascular function: a randomised, crossover study in healthy individuals.
Secondary ID [1] 262301 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platelet hyperactivation 268010 0
Blood pressure 268011 0
Condition category
Condition code
Diet and Nutrition 268142 268142 0 0
Other diet and nutrition disorders
Cardiovascular 268150 268150 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 30 g Chilli paste once daily for 8 days mixed into daily meals

This study is designed to compare the effects of acute and regular intake of 30 g of chilli paste and low dose (100mg) aspirin on platelet aggregation and brachial and central blood pressure.
The study consists of two 8 day intervention periods (2hr test on day 1, 1hr test on day 8), with a washout of at least 14 days between intervention periods.
On test days, blood samples will be collected when fasting and at regular intervals postprandially for either 1 or 2 hours. Subjects will consume meals during the 4 test sessions that consist of a meat (or soy alternative) patty in a bread roll and water, and are consumed with either the chilli or aspirin interventions.
Measures of blood pressure and blood vessel function will be collected every fifteen minutes for either 1 or 2 hours postprandially.
Comparisons will be made between the comparator and intervention on their effects after acute and regular consumption (8 days).
Intervention code [1] 266693 0
Prevention
Intervention code [2] 266694 0
Treatment: Other
Comparator / control treatment
100 mg Aspirin in an oral tablet once daily for 8 days
Control group
Active

Outcomes
Primary outcome [1] 266889 0
Platelet aggregation - measured in vitro by platelet aggregometry
Timepoint [1] 266889 0
For 2hr tests - fasting (immediately prior to the meal) and then at 60 minutes and 120 minutes
For 1 hr tests - fasting (immediately prior to the meal) and then at 60 minutes.
Secondary outcome [1] 276568 0
Brachial and central blood pressure measured with pulse wave analysis (PWA) technique
Timepoint [1] 276568 0
For 2 hr tests - fasting (immediately prior to the meal) and then every fifteen minutes for 120 minutes.
For 1 hr tests - fasting (immediately prior to the meal) and then every fifteen minutes for 60 minutes.
Secondary outcome [2] 276570 0
Plasma 6-keto prostaglandin F1a measured by ELISA method
Timepoint [2] 276570 0
For 2 hr tests - fasting (immediately prior to the meal) and then at 20, 40, 60, 90 and 120 minutes.
For 1 hr tests - fasting (immediately prior to the meal) and then at 20, 40, 60 minutes.
Secondary outcome [3] 276571 0
Plasma glucose and insulin
Timepoint [3] 276571 0
For 2 hr tests - fasting (immediately prior to the meal) and then at 5, 10, 20, 40, 60, 90 and 120 minutes.
For 1 hr tests - fasting (immediately prior to the meal) and then at 5, 10, 20, 40, 60 minutes.

Eligibility
Key inclusion criteria
No history of renal disease
No diabetes, liver disease or other heart conditions
Not currently taking aspirin or aspirin-like medication, NSAIDS, steroids or omega-3 fatty acid supplements
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have gluten intolerance

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation - computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267181 0
University
Name [1] 267181 0
University of Tasmania
Country [1] 267181 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Locked Bag 1320,
School of Human Life Sciences,
UTAS, Launceston 7250
Country
Australia
Secondary sponsor category [1] 266254 0
None
Name [1] 266254 0
Address [1] 266254 0
Country [1] 266254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269175 0
Human Reseach Ethics committee (Tasmania) Network
Ethics committee address [1] 269175 0
Private Bag 1
Hobart
Tasmania 7001
Ethics committee country [1] 269175 0
Australia
Date submitted for ethics approval [1] 269175 0
Approval date [1] 269175 0
14/12/2009
Ethics approval number [1] 269175 0
H0010934

Summary
Brief summary
Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in Australia. Increased blood pressure (hypertension) and hyper-activation, or clumping, of platelets are two of the major risk factors for CVD. Blood pressure increases with hardening and narrowing of the blood vessels. Platelets, small cells in the blood, normally form clumps to stop bleeding. In some conditions, however, this clumping action may lead to narrowing and hardening of the blood vessels and affects vascular function.
Aspirin is the ‘gold standard’ medication to prevent platelet aggregation, but regular aspirin use can cause damage to the lining of the stomach, resulting in bleeding. Previous research has found that chilli, a commonly used spice, can help prevent platelet aggregation.

The aim of this intervention study is to compare the effects of a single dose of aspirin/chilli and their regular intake, on platelet aggregation and various measures of vascular function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32693 0
Address 32693 0
Country 32693 0
Phone 32693 0
Fax 32693 0
Email 32693 0
Contact person for public queries
Name 15940 0
Dr Kiran Ahuja
Address 15940 0
Locked Bag 1320, School of Human Life Sciences,
University of Tasmania,
Launceston 7250
Country 15940 0
Australia
Phone 15940 0
+61 3 6324 5478
Fax 15940 0
Email 15940 0
[email protected]
Contact person for scientific queries
Name 6868 0
Dr Kiran Ahuja
Address 6868 0
Locked Bag 1320, School of Human Life Sciences,
University of Tasmania,
Launceston 7250
Country 6868 0
Australia
Phone 6868 0
+61 3 6324 5478
Fax 6868 0
Email 6868 0
[email protected]

No information has been provided regarding IPD availability


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
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