Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001608358
Ethics application status
Approved
Date submitted
10/11/2017
Date registered
7/12/2017
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Appearance of uric acid in blood following the consumption of beverages containing sucrose or isomaltulose by healthy adults
Scientific title
The effect in healthy adults of consuming sucrose or isomaltulose sweetened beverages on circulating uric acid concentration
Secondary ID [1] 293330 0
Nil known
Universal Trial Number (UTN)
U1111-1204-9107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperuricaemia 305420 0
Glycaemia 305421 0
Condition category
Condition code
Diet and Nutrition 304700 304700 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 304701 304701 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a crossover trial in which 12 healthy adults will ingest a 500ml 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 consume the intervention beverages 1.5hr following lunch. Eating lunch and subsequent blood sampling will be under the supervision of the study investigators.
Intervention code [1] 299585 0
Treatment: Other
Comparator / control treatment
This is a crossover trial, each person will act as his or her own comparator
Control group
Active

Outcomes
Primary outcome [1] 303912 0
Uricaemia
Timepoint [1] 303912 0
Postprandial monitoring of uric acid concentrations over a period of 3h following beverage ingestion. Capillary blood will be sampled via fingerprick at baseline at 30, 60, 90, 120 and 150 minutes following beverage ingestion.
Secondary outcome [1] 340439 0
Glycaemia
Timepoint [1] 340439 0
Postprandial monitoring of blood glucose concentrations over a period of 3h following beverage ingestion. 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 with normal fasting blood glucose concentration
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Having a fasting blood glucose concentration >6.1mmol/L indicative of impaired fasting glucose

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 order of treatments will be randomised and placed into sealed envelopes. Each time a new participant presents, the investigator will take the next envelope and open it to reveal the order allocation.
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 size of 11 has sufficient power to detect a between-treatment difference of 1SD in uricaemic area-under-the-curve (power 0.8, alpha 0.05).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/12/2018
Actual
Date of last participant enrolment
Anticipated
29/03/2019
Actual
Date of last data collection
Anticipated
3/06/2019
Actual
Sample size
Target
11
Accrual to date
Final
Recruitment outside Australia
Country [1] 9348 0
New Zealand
State/province [1] 9348 0
Otago

Funding & Sponsors
Funding source category [1] 297954 0
University
Name [1] 297954 0
University of Otago
Country [1] 297954 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] 297016 0
None
Name [1] 297016 0
Address [1] 297016 0
Country [1] 297016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298996 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 298996 0
Ethics committee country [1] 298996 0
New Zealand
Date submitted for ethics approval [1] 298996 0
13/10/2017
Approval date [1] 298996 0
16/10/2017
Ethics approval number [1] 298996 0
17/011

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

Contacts
Principal investigator
Name 78938 0
Dr Bernard Venn
Address 78938 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 78938 0
New Zealand
Phone 78938 0
+6434795068
Fax 78938 0
Email 78938 0
[email protected]
Contact person for public queries
Name 78939 0
Bernard Venn
Address 78939 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 78939 0
New Zealand
Phone 78939 0
+6434795068
Fax 78939 0
Email 78939 0
[email protected]
Contact person for scientific queries
Name 78940 0
Bernard Venn
Address 78940 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 78940 0
New Zealand
Phone 78940 0
+6434795068
Fax 78940 0
Email 78940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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.