Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000783820
Ethics application status
Approved
Date submitted
23/07/2012
Date registered
24/07/2012
Date last updated
2/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The glycaemic index of infant formula products
Scientific title
The glycaemic index of infant formula products assessed in healthy individuals
Secondary ID [1] 280893 0
Nil
Universal Trial Number (UTN)
U1111-1132-8842
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 286966 0
glycaemic index 286982 0
Condition category
Condition code
Diet and Nutrition 287303 287303 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants consume an infant formula and this is compared to the glucose response in the blood for 25g glucose. There are 17 infant formula's, made up from a powder mixed with water and 3 glucoses in all. 21.3g infant formula powder is added to 220ml water. Each formula is consumed once only. The participants come in on 20 seperate occassions, usually 2 to 3 times a week. The formula's are mixtures of lactose, glucose solids, dextrose, maltodextrin, galacto-oligosaccharides, fructo-oligosaccharides, oat fibre, apple fibre, docosahexanoic acid, arachidonic acid, alpha-linoleic acid and linoleic acid. Response is monitored for 120 minutes after consumption.
Intervention code [1] 285325 0
Treatment: Other
Comparator / control treatment
25g glucose in 220ml water. This is measured on three seperate occassions. Response is monitored for 120 minutes after consumption.
Control group
Active

Outcomes
Primary outcome [1] 287579 0
The glycaemic index of each of the infant formula's. This is the incremental area under the blood glucose curve of the formula in relation to a 25 g glucose reference
Timepoint [1] 287579 0
-5,0,15,30,45,60,90,120 minutes
Secondary outcome [1] 298442 0
Nil
Timepoint [1] 298442 0
Nil

Eligibility
Key inclusion criteria
healthy individuals with a fasting blood glucose below 5.6 mmol/L
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
fasting blood glucose above 5.6mmol/L
smoking

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)
Subjects respond to newspaper advertisements. They are randomised to the order in which they receive the infant formulas. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomization table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2012
Actual
20/07/2012
Date of last participant enrolment
Anticipated
30/07/2012
Actual
30/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment outside Australia
Country [1] 4419 0
New Zealand
State/province [1] 4419 0
Canterbury

Funding & Sponsors
Funding source category [1] 285681 0
Commercial sector/Industry
Name [1] 285681 0
Nutricia
Country [1] 285681 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute for Plant & Food Research
Address
Private Bag 4704, Christchurch 8140, Canterbury
Country
New Zealand
Secondary sponsor category [1] 284511 0
None
Name [1] 284511 0
Address [1] 284511 0
Country [1] 284511 0
Other collaborator category [1] 276963 0
Government body
Name [1] 276963 0
Lipid and Diabetes Research Group
Address [1] 276963 0
40 Stewart Street, Christchurch 8011, Canterbury
Country [1] 276963 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287669 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 287669 0
C/_ Ministry Of Health,
PO Box 3877, Christchurch 8140, Canterbury
Ethics committee country [1] 287669 0
New Zealand
Date submitted for ethics approval [1] 287669 0
Approval date [1] 287669 0
01/06/2011
Ethics approval number [1] 287669 0
CTB/04/02/007

Summary
Brief summary
The aim of this study is to evaluate to blood glucose response of a variety of infant formula products. The glycaemic index measures how blood glucose changes after a portion of food that contains 50g avaliable carbohydrate has been eaten. Teh benefit of the system is that it allows us to classify whether a food causes a large increase in blood glcuose after it is eaten, or if its response is lower and lasts for longer. Blood glucose control is especially important for people with diabetes as high levels of circulating glucose can cause cellular damage and increase their risk of coronary heart disease. Low GI foods will produce a smaller, longer lasting increase in blood glucose and hence consuming a diet high in low GI foods will improve blood glucose control in people with diabetes
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34472 0
Dr Alison Wallace
Address 34472 0
New Zealand Institute for Plant & Food Research Ltd
Private Bag 4704 Christchurch 8140
Country 34472 0
New Zealand
Phone 34472 0
+6433256400
Fax 34472 0
+6433252074
Email 34472 0
[email protected]
Contact person for public queries
Name 17719 0
Dr Alison Wallace
Address 17719 0
Private Bag 4704, Christchurch 8140, Canterbury
Country 17719 0
New Zealand
Phone 17719 0
+6433259638
Fax 17719 0
+6433252074
Email 17719 0
[email protected]
Contact person for scientific queries
Name 8647 0
Dr Alison Wallace
Address 8647 0
Private Bag 4704, Christchurch 8140, Canterbury
Country 8647 0
New Zealand
Phone 8647 0
+6433259638
Fax 8647 0
+6433252074
Email 8647 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.