Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000458639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Launceston chilli study
Scientific title
The effect of acute and medium-term chilli-containing foods on glucose tolerance, vascular compliance and other measures of cardiovascular disease risk in young to middle-aged adults: a randomized cross-over trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk 573 0
Glucose intolerance 574 0
Condition category
Condition code
Cardiovascular 649 649 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized cross-over trial compared the effects of a standard test meal either containing or not containing chilli puree in the context of a chilli-supplemented or chilli-free diet. Each background diet period lasted for 30 days, taken in random order. A chilli-free test meal was administered at day 26 of the chilli-free diet, a chilli-containing test meal at day 30 of the chilli-free diet, and a chilli-containing test meal at day 30 of the chilli-supplemented diet.
Intervention code [1] 590 0
None
Comparator / control treatment
Chilli-free diet
Control group
Active

Outcomes
Primary outcome [1] 767 0
Glucose tolerance: 2-hour standard meal challenge
Timepoint [1] 767 0
Secondary outcome [1] 1559 0
a) fasting plasma lipids at start of each challenge
Timepoint [1] 1559 0
Secondary outcome [2] 1560 0
b) vascular resistance
Timepoint [2] 1560 0
Secondary outcome [3] 1561 0
c) metabolic rate
Timepoint [3] 1561 0
At 7 intervals throughout the 2-hour challenge.

Eligibility
Key inclusion criteria
Adults eating a regular diet (e.g. not shift-work) which normally contains some chilli.
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes, gastrointestinal disease, symptomatic history of cardiovascular disease, tachy-arrythmias, hypertension, morbid obesity, thyroid disease, recent acute intercurrent illness or chronic inflammatory condition: anti-depressants, Viagra or similar, lipid-lowering medication: elite athletes.

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)
Allocation following recruitment from predetermined list, not concealed from research officer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 713 0
University
Name [1] 713 0
University of Tasmania
Country [1] 713 0
Australia
Funding source category [2] 714 0
Commercial sector/Industry
Name [2] 714 0
Masterfoods
Country [2] 714 0
Australia
Primary sponsor type
University
Name
School of Human Life Sciences, University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 594 0
None
Name [1] 594 0
None
Address [1] 594 0
Country [1] 594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1914 0
HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK: Medical
Ethics committee address [1] 1914 0
Ethics committee country [1] 1914 0
Australia
Date submitted for ethics approval [1] 1914 0
Approval date [1] 1914 0
Ethics approval number [1] 1914 0

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

Contacts
Principal investigator
Name 35644 0
Address 35644 0
Country 35644 0
Phone 35644 0
Fax 35644 0
Email 35644 0
Contact person for public queries
Name 9779 0
Ms Kiran Ahuja
Address 9779 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 9779 0
Australia
Phone 9779 0
+61 3 63245497
Fax 9779 0
+61 3 63243658
Email 9779 0
[email protected]
Contact person for scientific queries
Name 707 0
Professor Madeleine Ball
Address 707 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 707 0
Australia
Phone 707 0
+61 3 63245480
Fax 707 0
+61 3 63243658
Email 707 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
No additional documents have been identified.