Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000716460
Ethics application status
Approved
Date submitted
20/05/2016
Date registered
30/05/2016
Date last updated
30/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Glycaemic response to varying the proportions of carbohydrate and vegetables within a meal
Scientific title
The effect of consuming meals with different proportions of carbohydrate and vegetables by healthy young adults on glycaemic response
Secondary ID [1] 289257 0
None
Universal Trial Number (UTN)
U1111-1183-4253
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial glycaemia 298833 0
Condition category
Condition code
Diet and Nutrition 298894 298894 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 298970 298970 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a dietary intervention study in which healthy young adults will consume test meals with differing proportions of carbohydrate (rice or pasta based meals) and non-starchy vegetables. Half of the participants will be randomised to receive pasta-based meals and the other half to receive rice-based meals. Within each intervention group participants will consume a meal with 30g and 60g of available carbohydrate at two separate testing sessions. The amount of rice and pasta corresponding to the 30 and 60g available carbohydrate will be 100 and 200g, respectively. The amount of non-starchy vegetables on the plate will be 250 and 150g, respectively (ie: a gram for gram replacement of rice or pasta with non-starchy vegetables). The amount of mince and sauce will be constant at 200g. The total weight of each meal will be 550g. Participant’s blood glucose concentration will be measured prior to consuming the meal and then at 15, 30, 45, 60 and 90 minutes after this time point. The order of test meal consumption will be randomised. The meals will be served hot (>65 deg C). Participants will consume the meals with instruction to finish all of the food on the plate in their own time while under supervision at the study site. The washout period between successive lunch meals will be one week.
Intervention code [1] 294801 0
Lifestyle
Intervention code [2] 294857 0
Treatment: Other
Intervention code [3] 294858 0
Prevention
Comparator / control treatment
Participants will consume a third test meal with 45g of available carbohydrate at a separate testing session. This will act as the control as it is the amount of available carbohydrate that Diabetes New Zealand recommends individuals with type 2 diabetes mellitus to consume within a starchy food at a main meal. The meals with 30g and 60g of available carbohydrate represent a one serving (15g available carbohydrate) difference from this control meal.
Control group
Active

Outcomes
Primary outcome [1] 298364 0
Blood glucose concentration will be measured on fingerprick samples using a Hemocue glucose analyser at each timepoint. The blood glucose data will be plotted and incremental area-under-the-curve will be calculated using the trapezoidal rule.
Timepoint [1] 298364 0
Baseline and thereafter at 15, 30, 45, 60 and 90 min following consumption of test meal
Secondary outcome [1] 323945 0
Blood glucose concentration at 90 min
Timepoint [1] 323945 0
90 min following consumption of the test meal

Eligibility
Key inclusion criteria
Healthy university students
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A dietary requirement that we cannot cater to. There will be no other exclusion criteria.

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)
Participants will be randomly assigned to receive either rice or pasta-based meals and to the order they will receive the meals. The person who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated. Randomisation will be performed by the department statistician, the researchers will remain unaware of allocations until the laboratory phase.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Males will be block randomised to ensure equal sex distribution between the two groups, controlling for any potential sex variability in glycaemic response. Simple randomisation will be used for order treatment and all randomisation will be done using Stata statistical analysis software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Crossover refers to the different proportions of starchy carbohydrate and vegetables on the plate, each person consumes three meals in randomised order containing 30, 45 and 60g starchy carbohydrate. There is also a parallel component to the study in which participants will be randomised to the starchy carbohydrate of either rice or pasta-based meals.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 34 participants in both the pasta and rice arms of the study would have 90% power to detect a 30% difference in AUC at the alpha 0.05 level. It was decided to recruit more participants than this to allow for expected dropout. A 30% difference was chosen to be clinically relevant as this corresponds to the difference in AUC between a low and high GI food.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2016
Date of last participant enrolment
Anticipated
Actual
9/03/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 7887 0
New Zealand
State/province [1] 7887 0
Otago

Funding & Sponsors
Funding source category [1] 293634 0
University
Name [1] 293634 0
University of Otago
Country [1] 293634 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 292469 0
None
Name [1] 292469 0
Address [1] 292469 0
Country [1] 292469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295071 0
University of Otago Human Ethics Committee
Ethics committee address [1] 295071 0
PO Box 56
Dunedin
9054
Ethics committee country [1] 295071 0
New Zealand
Date submitted for ethics approval [1] 295071 0
02/02/2015
Approval date [1] 295071 0
16/02/2015
Ethics approval number [1] 295071 0
14/204

Summary
Brief summary
A randomised controlled crossover trial in which participant’s blood glucose concentrations will be measured following the consumption of three test meals. Each meal will have different proportions of carbohydrate and non-starchy vegetables. The amount of starchy carbohydrate on the plate will be 30, 45 and 60g. The comparator will be the meal containing 45g starchy carbohydrate.

There will also be a parallel design in which the the starchy carbohydrate will be rice or pasta. Participants will be randomised to either rice or pasta-based meals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66002 0
Dr Bernard Venn
Address 66002 0
University of Otago
Department of Human Nutrition
PO box 56
Dunedin
9054
Country 66002 0
New Zealand
Phone 66002 0
+6434795068
Fax 66002 0
Email 66002 0
[email protected]
Contact person for public queries
Name 66003 0
Dr Bernard Venn
Address 66003 0
University of Otago
Department of Human Nutrition
PO box 56
Dunedin
9054
Country 66003 0
New Zealand
Phone 66003 0
+6434795068
Fax 66003 0
Email 66003 0
[email protected]
Contact person for scientific queries
Name 66004 0
Dr Bernard Venn
Address 66004 0
University of Otago
Department of Human Nutrition
PO box 56
Dunedin
9054
Country 66004 0
New Zealand
Phone 66004 0
+6434795068
Fax 66004 0
Email 66004 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.