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Trial registered on ANZCTR


Registration number
ACTRN12618001137280
Ethics application status
Approved
Date submitted
2/07/2018
Date registered
11/07/2018
Date last updated
11/07/2018
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
Nil
Universal Trial Number (UTN)
U1111-1216-5727
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

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

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)
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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
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] 10600 0
New Zealand
State/province [1] 10600 0
Otago

Funding & Sponsors
Funding source category [1] 299970 0
University
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
Name
University of Otago
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 299351 0
None
Name [1] 299351 0
Address [1] 299351 0
Country [1] 299351 0

Ethics approval
Ethics application status
Approved
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
19/01/2017
Approval date [1] 300831 0
08/02/2017
Ethics approval number [1] 300831 0
H17/011

Summary
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

Contacts
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
+6434795068
Fax 84958 0
Email 84958 0
bernard.venn@otago.ac.nz
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
+6434795068
Fax 84959 0
Email 84959 0
bernard.venn@otago.ac.nz
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
+6434795068
Fax 84960 0
Email 84960 0
bernard.venn@otago.ac.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