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Trial registered on ANZCTR

Registration number

ACTRN12618000901202

Ethics application status

Approved

Date submitted

25/05/2018

Date registered

29/05/2018

Date last updated

29/05/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect on satiety and cognitive function following the ingestion of beverages containing sucrose or isomaltulose by healthy adults

Scientific title

The effect in healthy adults of consuming sucrose or isomaltulose sweetened beverages on measures of satiety and cognitive function

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1214-7109

Trial acronym

Linked study record

Health condition

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

Cognition

Satiety

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

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 75 healthy adults will ingest a 500ml sparkling water beverage containing either 50g of sucrose or a beverage containing a mix of 50g isomaltulose with 45mg sucralose. The order in which participants receive the beverages will be randomised to each person. There will be a minimum 2 day washout between beverages. Prior to the intervention, participants will be given a standard lunch of sushi and water. Participants will ingest the intervention beverages within 15 minutes 1.5hr following lunch. Eating lunch and subsequent assessment of satiety and tests of cognition will be under the supervision of the study investigators.

Intervention code [1]

Treatment: Other

Comparator / control treatment

This is a crossover trial with the sucrose beverage 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]

Subjective satiety will be quantified at baseline and at 30, 60, 90, 120 and 150 minutes following beverage ingestion.

Primary outcome [2]

A composite outcome comprising a battery of tests of cognitive function (word recall; audio-visual memory; trailmaking)

Timepoint [2]

Tests of cognition will be quantified at 45, 90 and 135 minutes following beverage ingestion.

Primary outcome [3]

Satiety assessed as subsequent energy intake

Timepoint [3]

Food and beverages ingested from 12pm to 12am of each test day

Secondary outcome [1]

Postprandial monitoring of blood glucose concentrations over a period of 3h following beverage ingestion.

Timepoint [1]

Capillary blood will be sampled via fingerprick at baseline at 30, 60, 90, 120 and 150 minutes following beverage 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

Intolerance to isomaltulose or sucralose

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 37 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 beverages to participants will be undertaken by a University staff member otherwise uninvolved in the study. Allocation concealment was 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

Using published data and assuming a within-person correlation of 0.5, a sample size of 70 is sufficient to detect a difference of 0.5 SD for the quality of memory, trailmaking and speed of attention tests using ANCOVA (Scholey et al., 2004). For satiety, 70 participants will have 80% power to detect a 5mm difference in VAS scores between trifles (Flint et al., 2000). To allow for dropout, 75 people will be recruited.

Scholey, AB and Kennedy, DO, Cognitive and physiological effects of an "energy drink": an evaluation of the whole drink and of glucose, caffeine and herbal flavouring fractions, Psychopharmacology (Berl), 2004; 176: 320-30.

Flint, A, Raben, A, Blundell, JE and Astrup, A, Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies, Int J Obes Relat Metab Disord, 2000; 24: 38-48.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/03/2018

Date of last participant enrolment

Anticipated

Actual

8/03/2018

Date of last data collection

Anticipated

Actual

6/04/2018

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
PO Box 56
Dunedin 9054

Country [1]

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]

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]

PO Box 56
Dunedin 9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

13/10/2017

Approval date [1]

16/10/2017

Ethics approval number [1]

17/011

Summary

Brief summary

It has been postulated that satiety and cognitive function are dependent upon the concentration of circulating blood glucose. The primary purpose of the study therefore, is to test whether measures of satiety and cognition are effected by differing concentrations of circulating blood glucose concentrations. To generate differences in blood glucose concentration, beverages sweetened with 50g of either sucrose or isomaltulose were developed. In order to match the beverages for sweetness, a small amount of sucralose was added to the isomaltulose beverage. A triangle taste test was undertaken in six people with the result that the two beverages were indistinguishable from one another. The blood glucose response to the test beverages was undertaken in a subset of 12 of the 75 participants. The tests of satiety and cognition were conducted in the afternoon. The order in which participants received the test beverages was randomised to each person. Each participant consumed both of the test drinks in a crossover design with a washout of at least two days. Standard test methodology was used to test for subjective and objective satiety. During the test period of three hours, a film was shown in three half hour time-slots with a 20 minute interval between each showing. During the three intervals, a standard word recall test was administered and participants answered questions relating to the section of film that had just been screened. One trailmaking test was administered at the end of each session. The people administering the tests and the participants were unaware of which beverage had just been consumed (double-blinding). Data analysis was undertaken by a biostatistician blinded to order of treatment. The study hypothesis was that a more stable blood glucose concentration over time, represented by the isomaltulose treatment, would result in greater satiety and a better cognitive performance.

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 effect on satiety of ingesting isosweet and isoenergetic sucrose- and isomaltulose-sweetened beverages: A randomised crossover trial.	2020	https://dx.doi.org/10.1017/S0007114520000884

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

Trial Review

Documents added manually

Documents added automatically