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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]

Nil

Universal Trial Number (UTN)

U1111-1216-5727

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Satiety

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Satiety assessed via the use of visual analogue scales (Likert) in response to four appetite questions (subjective).

Timepoint [1]

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]

Participants will record 24h food and beverage consumption via a weighed food record

Timepoint [2]

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]

Blood glucose concentration in response to trifle ingestion

Timepoint [1]

Baseline, 60 and 120 min following trifle ingestion

Eligibility

Key inclusion criteria

Healthy adults

Minimum age

18 Years

Maximum age

75 Years

Sex

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

24/02/2017

Date of last participant enrolment

Anticipated

Actual

3/03/2017

Date of last data collection

Anticipated

Actual

31/03/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

University of Otago
PO Box 56
Dunedin 9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

19/01/2017

Approval date [1]

08/02/2017

Ethics approval number [1]

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

Dr Bernard Venn

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+6434795068

Fax

[email protected]

Contact person for public queries

Name

Bernard Venn

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+6434795068

Fax

[email protected]

Contact person for scientific queries

Name

Bernard Venn

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+6434795068

Fax

[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

Source	Title	Year of Publication	DOI
Embase	The comparative effect on satiety and subsequent energy intake of ingesting sucrose or isomaltulose sweetened trifle: A randomized crossover trial.	2018	https://dx.doi.org/10.3390/nu10101504
Embase	The effect of postprandial glycaemia on cognitive function: a randomised crossover trial.	2020	https://dx.doi.org/10.1017/S0007114520000458

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically