Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000366550
Ethics application status
Approved
Date submitted
10/08/2006
Date registered
22/08/2006
Date last updated
22/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determination of the Glycemic Index of Breads
made from a Novel Wheat
Scientific title
A randomised study determining the glycemic index of breads made from novel wheat in healthy volunteers with a normal fasting glucose (3.5-5.5 mmol/L)
Secondary ID [1] 301 0
Commonwealth Scientific Industrial Research Organisation (CSIRO): HM71A
Universal Trial Number (UTN)
Trial acronym
Novel wheat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers with fasting glucose 3.5-5.5 mmol/L 1335 0
Condition category
Condition code
Metabolic and Endocrine 1423 1423 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be randomised to eat one meal of 100gm of bread from the new wheat flour (Yammamori) . There are 3 breads, 25%, 50% and 100% Yammamori wheat. The response to a reference carbohydrate (sugar drink) is used as a standard for comparison in these tests on 3 occasions due to the variability of the glucose response.
Intervention code [1] 1276 0
Lifestyle
Comparator / control treatment
One meal of 100gm of bread from conventional wheat. The response to a reference carbohydrate (sugar drink) is used as a standard for comparison in these tests on 3 occasions due to the variability of the glucose response.
Control group
Active

Outcomes
Primary outcome [1] 1945 0
Glucose blood samples
Timepoint [1] 1945 0
At each visit at times 0, 15, 30, 45, 60, 90 & 120 mins.
Secondary outcome [1] 3406 0
Insulin blood samples
Timepoint [1] 3406 0
At each visit at times 0, 15, 30, 45, 60, 90 & 120 mins.

Eligibility
Key inclusion criteria
Normal fasting blood glucose concentration (3.5-5.5 mmol/L).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of diabetes (self-reported)Sufferers of bleeding disordersKnown food allergy, hypersensitivity or intolerance to cereal foods (eg celiac sprue) Taking medications known to influence glucose tolerance (oral contraceptives are excepted) such as sulphonylureas, metformin and thiazolidinediones.Persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol Participation in another research study within 30 days preceding the start of this studyHistory or presence of GI, renal or hepatic disease of any cause.

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)
Volunteers will be randomly allocated by computer generated sequence to study treatments. The treatments are coded alphabetically. Locked computer files indicate treatment allocation numerically and the treatment code is concealed from research staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Volunteers will be initially blocked matched into 4 groups based on age, body mass index and gender, glucose level prior to randomisation by computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1555 0
Government body
Name [1] 1555 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 1555 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
Address
Country
Australia
Secondary sponsor category [1] 1368 0
None
Name [1] 1368 0
n/a
Address [1] 1368 0
Country [1] 1368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2987 0
CSIRO Human Nutrition
Ethics committee address [1] 2987 0
Ethics committee country [1] 2987 0
Australia
Date submitted for ethics approval [1] 2987 0
Approval date [1] 2987 0
21/04/2006
Ethics approval number [1] 2987 0
06/01

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

Contacts
Principal investigator
Name 35452 0
Address 35452 0
Country 35452 0
Phone 35452 0
Fax 35452 0
Email 35452 0
Contact person for public queries
Name 10465 0
Anne McGuffin
Address 10465 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10465 0
Australia
Phone 10465 0
+61 8 83038988
Fax 10465 0
+61 8 8303 8899
Email 10465 0
[email protected]
Contact person for scientific queries
Name 1393 0
Tony Bird
Address 1393 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1393 0
Australia
Phone 1393 0
+61 8 83038902
Fax 1393 0
+61 8 8303 8899
Email 1393 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.