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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] 294997 0
Nil known
Universal Trial Number (UTN)
U1111-1214-7109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 308019 0
Satiety 308020 0
Condition category
Condition code
Diet and Nutrition 307054 307054 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 307055 307055 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 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] 301339 0
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] 306027 0
Satiety assessed via the use of visual analogue scales (Likert) in response to four appetite questions (subjective).
Timepoint [1] 306027 0
Subjective satiety will be quantified at baseline and at 30, 60, 90, 120 and 150 minutes following beverage ingestion.
Primary outcome [2] 306028 0
A composite outcome comprising a battery of tests of cognitive function (word recall; audio-visual memory; trailmaking)
Timepoint [2] 306028 0
Tests of cognition will be quantified at 45, 90 and 135 minutes following beverage ingestion.
Primary outcome [3] 306053 0
Satiety assessed as subsequent energy intake
Timepoint [3] 306053 0
Food and beverages ingested from 12pm to 12am of each test day
Secondary outcome [1] 347385 0
Postprandial monitoring of blood glucose concentrations over a period of 3h following beverage ingestion.
Timepoint [1] 347385 0
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
Gender
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
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] 10507 0
New Zealand
State/province [1] 10507 0
Otago

Funding & Sponsors
Funding source category [1] 299583 0
University
Name [1] 299583 0
University of Otago
Address [1] 299583 0
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country [1] 299583 0
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] 298898 0
None
Name [1] 298898 0
Address [1] 298898 0
Country [1] 298898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300484 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 300484 0
PO Box 56
Dunedin 9054
Ethics committee country [1] 300484 0
New Zealand
Date submitted for ethics approval [1] 300484 0
13/10/2017
Approval date [1] 300484 0
16/10/2017
Ethics approval number [1] 300484 0
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 83806 0
Dr Bernard Venn
Address 83806 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 83806 0
New Zealand
Phone 83806 0
+6434795068
Fax 83806 0
Email 83806 0
bernard.venn@otago.ac.nz
Contact person for public queries
Name 83807 0
Dr Bernard Venn
Address 83807 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 83807 0
New Zealand
Phone 83807 0
+6434795068
Fax 83807 0
Email 83807 0
bernard.venn@otago.ac.nz
Contact person for scientific queries
Name 83808 0
Dr Bernard Venn
Address 83808 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 83808 0
New Zealand
Phone 83808 0
+6434795068
Fax 83808 0
Email 83808 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