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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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
Timepoint [1] 298442 0

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

Study design
Purpose of the study
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 4419 0
New Zealand
State/province [1] 4419 0

Funding & Sponsors
Funding source category [1] 285681 0
Commercial sector/Industry
Name [1] 285681 0
Address [1] 285681 0
37 Banks Road, Mt Wellington, Auckland 1060
Country [1] 285681 0
New Zealand
Primary sponsor type
Government body
New Zealand Institute for Plant & Food Research
Private Bag 4704, Christchurch 8140, Canterbury
New Zealand
Secondary sponsor category [1] 284511 0
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
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
Ethics approval number [1] 287669 0

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
Trial related presentations / publications
Public notes

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
Fax 34472 0
Email 34472 0
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
Fax 17719 0
Email 17719 0
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
Fax 8647 0
Email 8647 0

No information has been provided regarding IPD availability
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