Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001502426
Ethics application status
Approved
Date submitted
27/10/2016
Date registered
31/10/2016
Date last updated
31/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring a European Food Safety Authority health claim: Effect of Partial Sucrose Replacement with Fructose in sugary beverages on metabolic responses
Scientific title
Glycaemic, uricaemic and blood pressure effects of partial sucrose replacement with fructose in sugary beverages in young healthy adults
Secondary ID [1] 290394 0
Nil
Universal Trial Number (UTN)
U1111-1189-1340
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial glycaemic control 300727 0
Postprandial uricaemic control 300728 0
Postprandial blood pressure 300729 0
Condition category
Condition code
Diet and Nutrition 300564 300564 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 300565 300565 0 0
Metabolic disorders
Diet and Nutrition 300574 300574 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised crossover study involving five visits on five days. On two days, 12 healthy adults will receive beverages sweetened with 50g sucrose (duplicate control). On three days participants will receive beverages sweetened with 16.7g fructose + 33.3g sucrose; 25g fructose + 25g sucrose; and 33.3g fructose + 16.7g sucrose. Beverages will be consumed on mornings after an overnight fast. The order that the beverages are given will be randomised to each participant. Blood will be sampled via cannula by a registered nurse at intervals over two-hours following consumption of the beverages. The washout will be 2-7 days between treatments. All beverages will be given under supervision to ensure they are fully consumed. The study will be run by a MSc student in Human Nutrition under the supervision of a senior lecturer in the University of Otago Clinic Rooms.
Intervention code [1] 296226 0
Lifestyle
Intervention code [2] 296227 0
Treatment: Other
Intervention code [3] 296229 0
Prevention
Comparator / control treatment
A beverage sweetened with 50g sucrose will be used as the comparator/control.
Control group
Active

Outcomes
Primary outcome [1] 299981 0
Blood glucose response
Timepoint [1] 299981 0
Blood glucose concentrations will be measured at baseline (before consumption) and at 15, 30, 45, 60, 75, 90 and 120 minutes thereafter
Primary outcome [2] 299983 0
Blood uric acid concentration
Timepoint [2] 299983 0
Blood uric acid concentrations will be measured at baseline (before consumption) and at 15, 30, 45, 60, 75, 90 and 120 minutes thereafter
Secondary outcome [1] 328744 0
Postprandial blood pressure using a digital automatic blood pressure monitor (OMRON model Hem-907)
Timepoint [1] 328744 0
Blood pressure will be measured at baseline (before consumption) and at 15, 30, 45, 60, 75, 90 and 120 minutes thereafter.

Eligibility
Key inclusion criteria
Participants will be normoglycemic male and female adults aged between 18 and 60y inclusive.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of diabetes mellitus, cardiovascular disease, cancer, diseases of the digestive system; pregnant, known food allergies or taking medication that affects glucose absorption and metabolism.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who will determine whether a person is eligible for inclusion in the trial will be unaware, when this decision is made, to which order the person will be allocated. Allocation concealment will be achieved with the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A biostatistician will randomise the order of beverage type using a computerised sequence generation.
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
Statistical methods / analysis
The study will be powered to detect a 30% difference in incremental area under the curve (iAUC) between the sucrose control and the blended sugar test beverages. A difference of 30% iAUC has been associated with clinical benefit (Wolever et al, 1992). Using variability data from previous work, a sample size of 11 was adequate to detect a 30% reduction in iAUC with 80% power using the 5% level of significance. A sample of 12 was also sufficient to detect a 50% difference in uric acid AUC between control and test beverages. Blood pressure was a secondary outcome and the study was not powered for this factor.

A mixed effects regression model will be used to determine if there are any significant differences between the sucrose control and the glycemic and uricaemic responses to the test beverages. The model will be adjusted for treatment order. Uric acid concentrations are sex dependent, therefore the uric acid data will also be adjusted for sex.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/02/2016
Date of last participant enrolment
Anticipated
Actual
19/09/2016
Date of last data collection
Anticipated
Actual
5/10/2016
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 8353 0
New Zealand
State/province [1] 8353 0
Otago

Funding & Sponsors
Funding source category [1] 294800 0
University
Name [1] 294800 0
University of Otago
Country [1] 294800 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] 293639 0
None
Name [1] 293639 0
Address [1] 293639 0
Country [1] 293639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296199 0
University of Otago Human Ethics Committee
Ethics committee address [1] 296199 0
Ethics committee country [1] 296199 0
New Zealand
Date submitted for ethics approval [1] 296199 0
12/05/2015
Approval date [1] 296199 0
02/06/2015
Ethics approval number [1] 296199 0
15/075

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

Contacts
Principal investigator
Name 69950 0
Dr Bernard Venn
Address 69950 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 69950 0
New Zealand
Phone 69950 0
+6434795068
Fax 69950 0
Email 69950 0
[email protected]
Contact person for public queries
Name 69951 0
Bernard Venn
Address 69951 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 69951 0
New Zealand
Phone 69951 0
+643 4795068
Fax 69951 0
Email 69951 0
[email protected]
Contact person for scientific queries
Name 69952 0
Bernard Venn
Address 69952 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 69952 0
New Zealand
Phone 69952 0
+643 4795068
Fax 69952 0
Email 69952 0
[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
SourceTitleYear of PublicationDOI
EmbaseGlycaemic, uricaemic and blood pressure response to beverages with partial fructose replacement of sucrose.2018https://dx.doi.org/10.1038/s41430-018-0134-x
N.B. These documents automatically identified may not have been verified by the study sponsor.