ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Platelet hyperactivation

Blood pressure

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Cardiovascular

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]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

100 mg Aspirin in an oral tablet once daily for 8 days

Control group

Active

Outcomes

Primary outcome [1]

Platelet aggregation - measured in vitro by platelet aggregometry

Timepoint [1]

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]

Brachial and central blood pressure measured with pulse wave analysis (PWA) technique

Timepoint [1]

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]

Plasma 6-keto prostaglandin F1a measured by ELISA method

Timepoint [2]

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]

Plasma glucose and insulin

Timepoint [3]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Tasmania

Address [1]

Locked Bag 1320,
School of Human Life Sciences,
UTAS, Launceston 7250

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Reseach Ethics committee (Tasmania) Network

Ethics committee address [1]

Private Bag 1
Hobart
Tasmania 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/12/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Kiran Ahuja

Address

Locked Bag 1320, School of Human Life Sciences,
University of Tasmania,
Launceston 7250

Country

Australia

Phone

+61 3 6324 5478

Fax

kiran.ahuja@utas.edu.au

Contact person for scientific queries

Name

Dr Kiran Ahuja

Address

Locked Bag 1320, School of Human Life Sciences,
University of Tasmania,
Launceston 7250

Country

Australia

Phone

+61 3 6324 5478

Fax

kiran.ahuja@utas.edu.au

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

No additional documents have been identified.

Trial Review

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