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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 effect on satiety of young adults ingesting sucrose or isomaltulose sweetened food: a randomised crossover trial
Scientific title
The effect on young adults of ingesting sucrose or isomaltulose sweetened food on satiety and subsequent food intake
Secondary ID [1] 295379 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Satiety 308612 0
Condition category
Condition code
Metabolic and Endocrine 307563 307563 0 0
Normal metabolism and endocrine development and function

Study type
Description of intervention(s) / exposure
This will be a double-blind crossover trial in which 77 healthy adults will eat trifle for lunch containing either 73g of sucrose or isomaltulose. The order in which participants receive the trifles will be randomised to each person. There will be a 2 week washout between test days. After an overnight fast of 8h, on the mornings of the test days, participants will be provided with the same breakfast cereal to standardise the mormings food intake. The breakfast will be consumed at a time convenient to the participant, but at the same time on both test days. Between finishing breakfast and lunchtime, participants will be asked to abstain from food and drink, apart from water. At 12pm, participants will eat 446g of trifle within 15 minutes. Eating lunch and assessment of satiety questions will be under the supervision of the study investigators. Participants will record food and beverage intake throughout each test day (midnight to midnight)
Intervention code [1] 301700 0
Treatment: Other
Comparator / control treatment
This is a crossover trial with the sucrose trifle used as the comparator
Control group

Primary outcome [1] 306537 0
Satiety assessed via the use of visual analogue scales (Likert) in response to four appetite questions (subjective).
Timepoint [1] 306537 0
The set of four questions will be asked at baseline and at 30, 60, 90, 120 and 150 minutes after eating the trifles. The primary timepoint will be a summary measure area-under-the-curve up to 150min.
Primary outcome [2] 306538 0
Participants will record 24h food and beverage consumption via a weighed food record
Timepoint [2] 306538 0
24h period covering midnight to midnight on each test day. The primary outcome will be a summary measure of intake commencing after trifle consumption to 12am of the test day.
Secondary outcome [1] 348807 0
Blood glucose concentration in response to trifle ingestion
Timepoint [1] 348807 0
Baseline, 60 and 120 min following trifle ingestion

Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Food allergies to any of the trifle ingredients

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participant names will be entered into a dataset. A random number generator will be used to generate a random number next to each participant. The dataset will be sorted in ascending random number order. On the first test day, the first 39 participants in the sorted dataset will be allocated one treatment and the last 38 participants the alternative treatment; on the second test day, the treatments will be reversed (crossover). Randomisation and the supply of trifles to participants will be undertaken by a University staff member otherwise uninvolved in the study. Allocation concealment will be achieved by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A sample of 60 will be required to detect a difference of 0.5 standard deviations for all outcomes in standardised form. A larger number of participants will be recruited to allow for dropout. The study will have 90% power to the 1% significance level to detect this difference. Mixed effects regression analysis will be used to test for differences in satiety questions with participant as a random effect. Estimates will be adjusted for baseline and for the randomised order in which the participants received their trifles.

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] 10600 0
New Zealand
State/province [1] 10600 0

Funding & Sponsors
Funding source category [1] 299970 0
Name [1] 299970 0
University of Otago
Address [1] 299970 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country [1] 299970 0
New Zealand
Primary sponsor type
University of Otago
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Secondary sponsor category [1] 299351 0
Name [1] 299351 0
Address [1] 299351 0
Country [1] 299351 0

Ethics approval
Ethics application status
Ethics committee name [1] 300831 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 300831 0
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 300831 0
New Zealand
Date submitted for ethics approval [1] 300831 0
Approval date [1] 300831 0
Ethics approval number [1] 300831 0

Brief summary
The primary objectives will be to assess the effects of trifle sweetened with different sugars on satiety and day-long energy intakes. The sugars will induce different glycaemic responses in the participants. The study hypothesis is that a more stable blood glucose concentration over time, represented by the isomaltulose treatment, will result in greater satiety. The study will have a crossover design in which each participant will consume an isomaltulose and a sucrose sweetened trifle in randomized order. Participants will attend two laboratory sessions separated by two weeks. On the day before each test day, participants will be given a standardized individually boxed ready-to-eat breakfast cereal to consume on the morning of the test. The test will run from 12 noon to 5pm. A baseline blood sample collected via fingerprick will be taken. Following consumption of the trifle, satiety will be assessed using four questions with feelings of satiety recorded using validated visual analogue scales. The set of four questions will be asked at baseline and at 30, 60, 90, 120 and 150 minutes after eating the trifles. Capillary blood for testing blood glucose concentration will be taken via fingerprick at 60 and 120 minutes after baseline. Weighed diet records will be taken throughout each test day. Data analysis will be undertaken by a biostatistician blinded to treatment.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 84958 0
Dr Bernard Venn
Address 84958 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 84958 0
New Zealand
Phone 84958 0
Fax 84958 0
Email 84958 0
Contact person for public queries
Name 84959 0
Dr Bernard Venn
Address 84959 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 84959 0
New Zealand
Phone 84959 0
Fax 84959 0
Email 84959 0
Contact person for scientific queries
Name 84960 0
Dr Bernard Venn
Address 84960 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 84960 0
New Zealand
Phone 84960 0
Fax 84960 0
Email 84960 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