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Trial registered on ANZCTR


Registration number
ACTRN12615000744550
Ethics application status
Approved
Date submitted
15/06/2015
Date registered
20/07/2015
Date last updated
26/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of timing of kiwifruit ingestion relative to consumption of a breakfast cereal on the glycaemic response to the breakfast cereal
Scientific title
Kiwifruit will be consumed by healthy subjects at different times before and after consuming a breakfast cereal in order to determine at which time point relative to the cereal ingestion, the kiwifruit is most effective at reducing the blood glucose response to the cereal
Secondary ID [1] 286910 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemia 295328 0
Condition category
Condition code
Diet and Nutrition 295598 295598 0 0
Obesity
Metabolic and Endocrine 295652 295652 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be asked to consume a glycaemic (GI > 70) breakfast cereal (60 g) after an overnight fast. They will also be asked to consume the edible portion of two gold kiwifruit (200 g) either at 11 h, or 90 min or 30 min before, or at the same time as, or 30 min after consuming the breakfast cereal (ie at 10 pm, or 7.30 am or 8.30 am or 9.00 am or 9.30 am, with the cereal consumed at 9.00 am. Each time interval will be in a different session, with at least two days between sessions. Baseline blood glucose measurements will be taken immediately before the first food intake in the morning and at intervals afterward to allow blood glucose response profiles to be constructed for each occasion.
All consumed food is supplied and experimenter follows postprandial responses.
Intervention code [1] 292096 0
Lifestyle
Intervention code [2] 292144 0
Prevention
Comparator / control treatment
Breakfast cereal without kiwifruit
Control group
Active

Outcomes
Primary outcome [1] 295308 0
Blood glucose concentration
Timepoint [1] 295308 0
Capillary blood sampling by finger prick will be at 0 (baseline), 15, 30, 45, 60, 90,120 and 180 min after consuming the breakfast cereal in all treatments. Where kiwifruit is consumed 90 min before the cereal blood sampling will also be at 0, 15, 30, 45 minutes after the kiwifruit is consumed, and where the kiwifruit is consumed 30 min before the breakfast cereal blood sampling will be at 0, 15, 30 min after kiwifruit ingestion.
Secondary outcome [1] 315322 0
Appetite measured using a 100 mm visual analogue scale sampling 4 dimensions of appetite: hunger, fullness, desire to eat, predicted capacity to eat.
Timepoint [1] 315322 0
Appetite will be measured immediately before and at 15, 60, 120 and 180 min after consuming the cereal.
Secondary outcome [2] 315323 0
Breath hydrogen
Timepoint [2] 315323 0
Will be measured at 8.30 am, half an hour before consuming the cereal.

Eligibility
Key inclusion criteria
Willingness to meet the requirements of the study, that is, to follow instructions to fast overnight and to not consume food other than the trial meal during the blood glucose measurement periods.
Not intolerant of kiwifruit or gluten.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Glucose intolerance

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 will be recruited by flyer and email.
Each subject will receive all experimental treatments.
The order of treatments for each subject is determined by computer-generated random number.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An on-line random number generator will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
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 outside Australia
Country [1] 6978 0
New Zealand
State/province [1] 6978 0
Manawatu

Funding & Sponsors
Funding source category [1] 291471 0
Commercial sector/Industry
Name [1] 291471 0
Zespri International Limited
Address [1] 291471 0
400 Maunganuir Rd,
Mt Maunganui 3149
Country [1] 291471 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
New Zealand Institute for Plant & Food Research Limited
Address
Private Bag 11600
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 290149 0
Commercial sector/Industry
Name [1] 290149 0
Zespri International Limited
Address [1] 290149 0
400 Maunganui Rd.,
Mt Maunganui 3149
Country [1] 290149 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293019 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 293019 0
PO Box 5013
Wellington 6011
Ethics committee country [1] 293019 0
New Zealand
Date submitted for ethics approval [1] 293019 0
Approval date [1] 293019 0
15/06/2015
Ethics approval number [1] 293019 0
NZ/1/AD08020

Summary
Brief summary
The aim of the study is to determine how much the proximity of kiwifruit ingestion to ingestion of a glycaemic breakfast cereal affects the ability of the kiwifruit to reduce the blood glucose raising effect of the breakfast cereal. Kiwifruit (200 g edible portion) will be consumed 11 h, 90 min, and 30 min before, at the same time as, and 30 min after consuming the breakfast cereal. Blood glucose responses will be measured to allow calculation of the blood glucose response as the area under the blood glucose response curve.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58102 0
Dr John Monro
Address 58102 0
New Zealand Institute for Plant & Food Research Limited,
Private Bag 11600
Palmerston North 4442
Country 58102 0
New Zealand
Phone 58102 0
+64 6 3556137
Fax 58102 0
Email 58102 0
john.monro@plantandfood.co.nz
Contact person for public queries
Name 58103 0
Dr Suman Mishra
Address 58103 0
New Zealand Institute for Plant & Food Research Limited,
Private Bag 11600
Palmerston North 4442
Country 58103 0
New Zealand
Phone 58103 0
+64 6 3556146
Fax 58103 0
Email 58103 0
suman.mishra@plantandfood.co.nz
Contact person for scientific queries
Name 58104 0
Dr John Monro
Address 58104 0
New Zealand Institute for Plant & Food Research Limited,
Private Bag 11600
Palmerston North 4442
Country 58104 0
New Zealand
Phone 58104 0
+64 6 3556137
Fax 58104 0
Email 58104 0
john.monro@plantandfood.co.nz

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