Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000692437
Ethics application status
Approved
Date submitted
24/05/2016
Date registered
26/05/2016
Date last updated
26/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of altering the proportions of meal components on subsequent energy intake: a randomised controlled trial.
Scientific title
The effect of altering the proportions of meal components on subsequent energy intake of healthy young adults : a randomised controlled trial.
Secondary ID [1] 289289 0
None
Universal Trial Number (UTN)
U1111-1183-1698
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 298876 0
Condition category
Condition code
Diet and Nutrition 298948 298948 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a crossover trial in which participants are to consume a mid-day test meal consisting of a starchy food, non-starchy vegetables and mince in a bolognaise sauce. Pasta and rice will be used, such that half of the subjects will consume three pasta meals and the other half will consume three rice meals. Among the three meals, the amount of available carbohydrate in the starchy food will be 30, 45 or 60 g. The meal containing 45 g of available carbohydrate is the reference meal. The meals containing 30 or 60 g of available carbohydrate differ to the reference meal in that they contain one less or one additional serving of starchy food (15 g of available carbohydrate). The amount of rice and pasta on the plate corresponding to the 30, 45 and 60g available carbohydrate will be 100, 150 and 200g. The amount of vegetables on the plate will be 250, 200 and 150, respectively. The amount of mince with pasta sauce will be constant among the meals (200g). Overall, the total weight of food in all of the meals will be 550g. On each testing day, participants will record their food and beverage intake for the entire day (0000 to 2359 hrs) and subsequent energy intake will be measured following the consumption of the entire test meal. The washout period will be one week. The meals will be served hot (>65 deg C) and consumed within the testing facility. Participants will be instructed to fast for 2 and a half hours before the lunch. They will be free to eat at their own pace meal consumption will be supervised to ensure that entire meal is consumed .
Intervention code [1] 294840 0
Lifestyle
Intervention code [2] 294855 0
Treatment: Other
Intervention code [3] 294856 0
Prevention
Comparator / control treatment
Consumption of the meal containing 45 g of available carbohydrate is the control treatment. The amount of available carbohydrate contained within in this meal is based on a New Zealand healthy plate model. Many factors influence the amount of carbohydrates people consume, therefore 45 g may not be suitable for all.
Control group
Active

Outcomes
Primary outcome [1] 298416 0
Energy intake for the remainder of the day following a lunch meal. The energy intake will be assessed by having participants record all food and beverage consumption. The participants will be given electronic scales accutate to 1g and instruction on how to weigh their food items.
Timepoint [1] 298416 0
Dietary energy intake following a lunch meal up until 23:59 of the same day
Secondary outcome [1] 324072 0
Dietary energy intake preceding a lunch meal. The energy intake will be assessed by having participants record all food and beverage consumption. The participants will be given electronic scales accutate to 1g and instruction on how to weigh their food items.
Timepoint [1] 324072 0
Dietary energy intake over the portion of the day starting at 24:00 to the beginning of a lunch meal
Secondary outcome [2] 324073 0
Daily dietary energy intake on the day of test. The energy intake will be assessed by having participants record all food and beverage consumption. The participants will be given electronic scales accutate to 1g and instruction on how to weigh their food items.
Timepoint [2] 324073 0
Dietary energy intake consumed over the period 24:00 to 23:59 on the test day

Eligibility
Key inclusion criteria
University students
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Food allergies or restrictions that cannot be catered for. We will be providing lunch meals and 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)
The person who will determine a persons eligiblity will be unaware, when this decision is made, to which group the person 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)
The method of sequence generation will be by permuted block randomisation. Block randomisation will be used to balance males and females into each of the intervention groups (rice or pasta). Computerised sequence generation will be used to randomise to order of treatment and week and time of laboratory sessions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Washout of one week
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size (n=80) allowing 39 in each intervention group will be sufficient to detect a 25% difference in energy intake post-test meal between meal size treatments with 80% power (using a mean energy intake of 4000 kJ, a standard deviation of the log of energy intake of 0.5 and a correlation of 0.55 between paired observations).
To analyse the percentage change in energy intake in response to test meal consumption, a mixed effects regression analysis will be undertaken.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2016
Date of last participant enrolment
Anticipated
Actual
25/03/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
77
Recruitment outside Australia
Country [1] 7896 0
New Zealand
State/province [1] 7896 0
Otago

Funding & Sponsors
Funding source category [1] 293665 0
University
Name [1] 293665 0
University of Otago
Country [1] 293665 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] 292500 0
None
Name [1] 292500 0
Address [1] 292500 0
Country [1] 292500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295104 0
University of Otago Human Ethics Committee
Ethics committee address [1] 295104 0
Ethics committee country [1] 295104 0
New Zealand
Date submitted for ethics approval [1] 295104 0
02/02/2015
Approval date [1] 295104 0
16/02/2015
Ethics approval number [1] 295104 0
14/204

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

Contacts
Principal investigator
Name 66150 0
Dr Bernard Venn
Address 66150 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin
9054
Country 66150 0
New Zealand
Phone 66150 0
+6434795068
Fax 66150 0
Email 66150 0
[email protected]
Contact person for public queries
Name 66151 0
Bernard Venn
Address 66151 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin
9054
Country 66151 0
New Zealand
Phone 66151 0
+6434795068
Fax 66151 0
Email 66151 0
[email protected]
Contact person for scientific queries
Name 66152 0
Bernard Venn
Address 66152 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin
9054
Country 66152 0
New Zealand
Phone 66152 0
+6434795068
Fax 66152 0
Email 66152 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.