Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001068156
Ethics application status
Approved
Date submitted
26/07/2019
Date registered
31/07/2019
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute cognitive, mood and satiety effects of different glycaemic responses
Scientific title
Acute effects in healthy adults of sweetened beverage ingestion inducing different glycaemic responses on tests of cognition, mood and satiety
Secondary ID [1] 298821 0
None
Universal Trial Number (UTN)
U1111-1237-4734
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition 313775 0
mood 313776 0
satiety 313777 0
Condition category
Condition code
Mental Health 312180 312180 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 312241 312241 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 55 healthy adults will drink three kinds of sweetened beverages; a drink containing 50g sucrose as the higher glycaemic response arm, a drink containing 50g isomaltulose and 0.035g sucralose as the lower glycaemic response arm, and a drink containing 0.12g sucralose as the negative control arm. The order in which participants receive the drinks will be randomised to each person. On the evening prior to the test day, participants will be asked to fast from 9pm onwards with water only being permitted, resulting in an overnight fast of 10 hours. On the mornings of the test days, participants will be provided with a 500ml beverage and asked to drink it within 10 minutes. There will be at least one-week washout between test days. On the day prior to each test, an email will be sent to participants to remind them to fast from 9pm onwards.
Intervention code [1] 315113 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] 320849 0
Cognitive function assessed via the Complex Figure test, the Word Recall test, the Trail Making test (Part B) and the Stroop Word Colour test.
Timepoint [1] 320849 0
The cognitive tests will be conducted 60minutes following beverage ingestion.
Primary outcome [2] 320850 0
Mood assessed via the use of visual analogue scales in response to eight questions related to mood states.
Timepoint [2] 320850 0
Mood questionnaires will be answered before and 60 minutes following beverage ingestion.
Primary outcome [3] 320851 0
Satiety assessed via the use of visual analogue scales in response to four appetite questions.
Timepoint [3] 320851 0
Satiety questionnaires will be answered before and 30, 60, and 90 minutes following beverage ingestion.
Secondary outcome [1] 373043 0
Blood glucose concentration in response to beverage ingestion
Timepoint [1] 373043 0
Baseline, 30, 60, 90, 120, and 150 minutes following beverage ingestion

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, breastfeeding, a diagnosis of pre-diabetes or diabetes, high blood pressure, heart disease, cancer, high cholesterol levels, liver disease, kidney disease, intestinal disease and clinical depression, or intolerance to or allergy to sucralose or isomaltulose, colour blind

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)
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which order of beverage ingestion the subject would be allocated. The treatment order was known only to a research assistant otherwise uninvolved in the study, neither the principal investigators nor the participants were aware of the order at the time of testing.
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
To detect a small difference of 0.3SD between treatments, at least 52 participants will be required for 80% power at the 5% significance level. To balance the number of participants for each drink order, 54 participants will be needed. Mixed effects regression analysis will be used to test for differences in cognitive tests results with participant ID as a random effect. Estimates will be adjusted by the order of drinks, whether sleeping well in the previous night, whether using alcohol usage 24 hours before each visit, the degree of drowsiness before the test, and the degree of hunger before the test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/01/2019
Date of last participant enrolment
Anticipated
Actual
14/03/2019
Date of last data collection
Anticipated
Actual
3/04/2019
Sample size
Target
54
Accrual to date
Final
55
Recruitment outside Australia
Country [1] 21714 0
New Zealand
State/province [1] 21714 0

Funding & Sponsors
Funding source category [1] 303372 0
University
Name [1] 303372 0
University of Otago
Country [1] 303372 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] 303404 0
None
Name [1] 303404 0
Address [1] 303404 0
Country [1] 303404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303902 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 303902 0
Ethics committee country [1] 303902 0
New Zealand
Date submitted for ethics approval [1] 303902 0
30/11/2018
Approval date [1] 303902 0
21/01/2019
Ethics approval number [1] 303902 0
H18/139

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95190 0
Dr Bernard Venn
Address 95190 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 95190 0
New Zealand
Phone 95190 0
+64 479 5068
Fax 95190 0
Email 95190 0
[email protected]
Contact person for public queries
Name 95191 0
Bernard Venn
Address 95191 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 95191 0
New Zealand
Phone 95191 0
+64 479 5068
Fax 95191 0
Email 95191 0
[email protected]
Contact person for scientific queries
Name 95192 0
Bernard Venn
Address 95192 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 95192 0
New Zealand
Phone 95192 0
+64 479 5068
Fax 95192 0
Email 95192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.