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Trial registered on ANZCTR


Registration number
ACTRN12615000721505
Ethics application status
Approved
Date submitted
15/06/2015
Date registered
13/07/2015
Date last updated
2/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Satiating effects of different carbohydrate foods within a mixed meal
Scientific title
A randomised repeated measures design in which healthy subjects will consume three different carbohydrate staples (rice, potato, pasta) in random order, each with the same meat and vegetable complement (Bolognese-type sauce), on different days, and score their satiety using a visual analogue scale for three hours after each meal in order to assess the ability of the scale to discriminate between the meals on the basis of appetite.
Secondary ID [1] 286908 0
Nil
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295326 0
Diabetes 295390 0
Condition category
Condition code
Diet and Nutrition 295596 295596 0 0
Obesity
Metabolic and Endocrine 295653 295653 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary intervention in which participants consume about 250 g of different staples (potato, rice, pasta), in three different meals, in which each of the staples is consumed with the same meat and vegetable sauce. The meals will be consumed at midday, each on a different day. Washout period between treatments was 24 h.
Intervention code [1] 292094 0
Lifestyle
Intervention code [2] 292146 0
Treatment: Other
Comparator / control treatment
Comparison is of the three staples. No separate control is required
Control group
Active

Outcomes
Primary outcome [1] 295306 0
Appetite during 3 h post-meal measured at several time points using 100 mm visual analogue scales that sample four dimensions: hunger, fullness, desire to eat, and capacity for food.
Timepoint [1] 295306 0
Immediately before meal, immediately after meal, 30 min after meal, 60 min, 120 and 180 min after meal
Secondary outcome [1] 315316 0
None
Timepoint [1] 315316 0
None

Eligibility
Key inclusion criteria
Healthy, no gastrointestinal disorders, no history of intolerance of the diets.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of intolerance of the diets.
Gatsrointestinal disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited by flyer and a general email.
Each subject will receive all treatments, each on a different day. The order of treatments for each individual will be determined by computer randomisation.
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online 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] 6977 0
New Zealand
State/province [1] 6977 0
Manawatu

Funding & Sponsors
Funding source category [1] 291466 0
Government body
Name [1] 291466 0
New Zealand Institute for Plant & Food Research Limited
Address [1] 291466 0
Private Bag 11 600,
Palmerston North 4442
Country [1] 291466 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute for Plant & Food Research
Address
Private Bag 11600,
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 290188 0
None
Name [1] 290188 0
Address [1] 290188 0
Country [1] 290188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293015 0
Health and Disability Ethics Committee
Ethics committee address [1] 293015 0
PO Box 5013,
Wellington 6011
Ethics committee country [1] 293015 0
New Zealand
Date submitted for ethics approval [1] 293015 0
Approval date [1] 293015 0
15/06/2015
Ethics approval number [1] 293015 0
NZ/1/9D08011

Summary
Brief summary
The aim of the study is to determine whether differences in satiation due to the consumption of different carbohydrate staples, each in a separate mixed meal, will have effects on satiety that are large enough for satiety data to be used in a resource that is being developed as an aid to healthier food choices in diabetes management. Subjects will consume each of the staples within a mixed meal, on different days, and score their satiety using a widely used visual analogue scale, for three hours after consuming each meal.
Trial website
Trial related presentations / publications
There are no trial-related citations
Public notes

Contacts
Principal investigator
Name 58094 0
Dr John Monro
Address 58094 0
New Zealand Institute for Plant & Food Research Limited.
Plant and Food Research,
Private Bag 11 600,
Palmerston North 4442
Country 58094 0
New Zealand
Phone 58094 0
+64 6 3556137
Fax 58094 0
Email 58094 0
john.monro@plantandfood.co.nz
Contact person for public queries
Name 58095 0
Dr John Monro
Address 58095 0
New Zealand Institute for Plant & Food Research limited,
Plant and Food Research,
Private Bag 11 600,
Palmerston North 4442
Country 58095 0
New Zealand
Phone 58095 0
+64 6 3556137
Fax 58095 0
Email 58095 0
john.monro@plantandfood.co.nz
Contact person for scientific queries
Name 58096 0
Dr John Monro
Address 58096 0
New Zealand Institute for Plant & Food Research Limited,
Plant and Food Research,
Private Bag 11 600,
Palmerston North 4442
Country 58096 0
New Zealand
Phone 58096 0
+64 6 3556137
Fax 58096 0
Email 58096 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