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Trial registered on ANZCTR


Registration number
ACTRN12609000890235
Ethics application status
Approved
Date submitted
29/10/2008
Date registered
12/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
To investigate the acute effects of different doses of chilli ingestion on blood glucose, insulin, blood vessel function and energy expenditure.
Scientific title
A radomised crossover study to determine the doses at which capsaicin affects blood glucose and insulin in healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postprandial hyperglycemia 3896 0
postprandial hyperinsuliemia 3897 0
Condition category
Condition code
Diet and Nutrition 4095 4095 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised crossover trial comparing the effects of a standard test bland meal to four standard meals containing different amounts of chilli. The standard meal consisted of a bread roll, beef burger and glucose drink. Three meals contained chilli paste/blend (20g, 30g and 40g) while two capsules containing 1.5g of chilli powder, with an equivalent capsaicin content of 40g of chilli paste/blend, were included in a fourth meal. Participants consumed each of the five meals over five visits, in random order, with a one week washout period between consecutive visits.

Chilli blend (a commercial product) was made of chillies, sugar, food acid and water.
Intervention code [1] 3622 0
Other interventions
Comparator / control treatment
chilli-free bland meal
Control group
Active

Outcomes
Primary outcome [1] 4989 0
Glucose tolerance - 2-hour standard meal challange. Glucose was measured by blood analysis.
Timepoint [1] 4989 0
Samples were taken after a overnight fast (10 to 12 hours), and 20, 40, 60, 90 and 120 minutes postprandially.
Primary outcome [2] 253059 0
Insulin measured by blood analysis.
Timepoint [2] 253059 0
Samples were taken after a overnight fast (10 to 12 hours), and 20, 40, 60, 90 and 120 minutes postprandially.
Secondary outcome [1] 8424 0
Platelet aggregation measured using adenosine diphosphate (ADP) induced platelet aggregation.
Timepoint [1] 8424 0
Samples were taken after a overnight fast (10 to 12 hours), one hour and two hours postprandially.
Secondary outcome [2] 8425 0
C-peptide measured by blood analysis.
Timepoint [2] 8425 0
Samples were taken after a overnight fast (10 to 12 hours), and 20, 40, 60, 90 and 120 minutes postprandially.
Secondary outcome [3] 257879 0
Brachial blood pressure measured using an electronic blood pressure monitor.
Timepoint [3] 257879 0
Readings were taken after a overnight fast (10 to 12 hours), and 20, 40, 60, 90 and 120 minutes postprandially. Muliple readings were recorded at each timepoint.
Secondary outcome [4] 257880 0
Aortic blood pressure measured using pulse wave analysis.
Timepoint [4] 257880 0
Readings were taken after a overnight fast (10 to 12 hours), and 20, 40, 60, 90 and 120 minutes postprandially. Muliple readings were recorded at each timepoint.
Secondary outcome [5] 257881 0
Arterial stiffness measured using pulse wave analysis.
Timepoint [5] 257881 0
Readings were taken after a overnight fast (10 to 12 hours), and 20, 40, 60, 90 and 120 minutes postprandially. Muliple readings were recorded at each timepoint.
Secondary outcome [6] 257882 0
Metabolic rate using gas exchange technique.
Timepoint [6] 257882 0
data collected at fasting and continously upto 2hours after completion of meal.

Eligibility
Key inclusion criteria
Adults eating a regular diet (i.e. non- shift workers)
Minimum age
21 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
known history of heart, liver or renal disease. taking medication for hypertension, diabetes, heart, liver or renal disease

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 a 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
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)
Recruitment postcode(s) [1] 1222 0
7250

Funding & Sponsors
Funding source category [1] 4088 0
University
Name [1] 4088 0
University of Tasmania (UTAS)
Address [1] 4088 0
1 Newnham Drive
Launceston 7250
Tasmania
Country [1] 4088 0
Australia
Primary sponsor type
Individual
Name
Dr. Kiran DK Ahuja
Address
School of Human Life Sciences UTAS Locked Bag 1320 Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 3681 0
Individual
Name [1] 3681 0
Professor Madeleine Ball
Address [1] 3681 0
School of Human Life Sciences UTAS
Locked Bag 1320 Launceston TAS 7250
Country [1] 3681 0
Australia
Other collaborator category [1] 456 0
Individual
Name [1] 456 0
Dr. Iain Robertson
Address [1] 456 0
School of Human Life Sciences UTAS
Locked Bag 1320 Launceston TAS 7250
Country [1] 456 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6159 0
Human Research Ethics Committee (Tasmanian) Network
Ethics committee address [1] 6159 0
Private Bag 01 Hobart
Tasmania 7001
Ethics committee country [1] 6159 0
Australia
Date submitted for ethics approval [1] 6159 0
Approval date [1] 6159 0
22/08/2006
Ethics approval number [1] 6159 0
H0009037

Summary
Brief summary
We have previously observed that adding chilli to a meal reduces the need for extra insulin to control the blood glucose. This finding is interesting and needs further investigation. Insulin is required to control blood glucose, however in some people the body produces more insulin than is required. This condition over long periods leads to hyperinsulinaemia and/or insulin resistant states, where in the insulin produced become inefficient and this may lead to type 2 diabetes and metabolic syndrome and heart disease.
As mentioned earlier our previous study showed a possible beneficial effect by controlling for insulin secretion as well as insulin clearance from the body. In the present study we plan to test the effects of different doses of chilli taken as food or in a capsule supplement on blood glucose and insulin. This study aims; to investigate the minimum dose of chilli required to show significant effects on blood glucose and insulin concentration, to investigate and compare the effects of chilli intake as food and as a capsule supplement on blood glucose and insulin concentrations and platelet function, to investigate and compare the effects of chilli intake as food and as a capsule supplement on blood pressure, functioning of blood vessels and metabolic rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29079 0
Address 29079 0
Country 29079 0
Phone 29079 0
Fax 29079 0
Email 29079 0
Contact person for public queries
Name 12236 0
Dr. Kiran Ahuja
Address 12236 0
School of Human Life Sciences
University of Tasamania (UTAS)
Locked Bag 1320 Launceston TAS 7250
Country 12236 0
Australia
Phone 12236 0
+61 3 63245478
Fax 12236 0
+61 3 63243658
Email 12236 0
kiran.ahuja@utas.edu.au
Contact person for scientific queries
Name 3164 0
Dr. Kiran Ahuja
Address 3164 0
School of Human Life Sciences
University of Tasamania (UTAS)
Locked Bag 1320 Launceston TAS 7250
Country 3164 0
Australia
Phone 3164 0
+61 3 63245478
Fax 3164 0
+61 3 63243658
Email 3164 0
kiran.ahuja@utas.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary