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Trial registered on ANZCTR


Registration number
ACTRN12620000970943
Ethics application status
Approved
Date submitted
29/07/2020
Date registered
28/09/2020
Date last updated
28/09/2020
Date data sharing statement initially provided
28/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of regular consumption of artificial sweetener on blood glucose levels in Type 2 diabetic patients
Scientific title
Effect of regular consumption of non-nutritive sweeteners (artificial sweeteners) on glucose homeostasis in Type 2 diabetic patients
Secondary ID [1] 301895 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetic 318401 0
Condition category
Condition code
Diet and Nutrition 316413 316413 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 316414 316414 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomized parallel design study and participants will be randomized to consume daily either 1. 600 ml artificially sweetened soft drink (acelfame K+ aspartame) 2. 600 ml sugar sweetened soft drink and 3. 600ml soda water for 12 weeks.

Arm 1: Artificially sweetened soft drink
Arm 2: Regular soft drink
Arm 3: Soda water

The average artificial sweetener content in the artificially sweetened drink is approximately 147mg aspartame and 79mg acelfame K per 600ml drink (arm 1).

The average sugar content in regular soft drink is approximately 57g/600ml drink (arm 2).

The participants can consume 600 ml of the test product (depending upon their respective allocation) any time of the day depending on their choice/convenience. All the drinks will be provided to the participants. To monitor compliance, the participants will be asked to complete a daily drink record sheet to record the quantity of drink consumed and
to bring the empty bottles back.
Intervention code [1] 318181 0
Lifestyle
Comparator / control treatment
Comparator arm: Regular soft drink
Control arm: Soda water
Control group
Active

Outcomes
Primary outcome [1] 324568 0
Daily average glucose measured with continuous glucose monitor (CGM) as percentage time above 10 mmol/L
Timepoint [1] 324568 0
2 week and 12 week post- intervention commencement
Secondary outcome [1] 384993 0
Change in HbA1c from baseline
Timepoint [1] 384993 0
At Baseline and at 12 weeks post intervention
Secondary outcome [2] 384994 0
Change in weight from baseline using a calibrated digital weighing scale.
Timepoint [2] 384994 0
At Baseline and at 12 week post intervention

Eligibility
Key inclusion criteria
• Age> 18 years, Both men and women. Not pregnant or breast-feeding females only.
• Type 2 diabetic with blood sugar controlled with diet or medication of any type.
• Current soft drink user but ready to switch to soda water or artificially sweetened beverages.
• No known allergies/intolerances to the artificial sweeteners.
• No consumption in the last 2 weeks of ASB or regular NNS consumption in other food forms
• Agreeable to consuming 600 ml daily artificially sweetened soft drink or regular soft drink or soda water daily for 12 weeks.
• Willing to wear a continuous glucose monitoring system and scan the sensor at least 4 times/day.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Do not have type 2 diabetes.
• Women who are pregnant or breast feeding or wish to become pregnant.
• Not a soft drink consumer.
• Are allergic to adhesive or have sensitive skin.
• Not comfortable to be randomized to any one of the experimental groups.

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)
Following initial contact with the university potential subjects will be screened and randomly allocated to one of the arms of the study. Block randomization will be used. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random balanced number sequence generator (randomization.com)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA with 2 factors, time (baseline and at 12 week) and treatment (ASB, soda water or regular soft drink) will be performed with BMI (and baseline HbA1c for CGM data and baseline CGM for HbA1c data) as a covariate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/08/2020
Date of last participant enrolment
Anticipated
15/12/2021
Actual
Date of last data collection
Anticipated
9/03/2022
Actual
Sample size
Target
120
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306308 0
University
Name [1] 306308 0
University of South Australia
Country [1] 306308 0
Australia
Primary sponsor type
University
Name
Unievrsity of South Australia
Address
University of South Australia, Clinical and Health Sciences, GPO Box 2471 Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 306803 0
None
Name [1] 306803 0
Address [1] 306803 0
Country [1] 306803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306523 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 306523 0
Ethics committee country [1] 306523 0
Australia
Date submitted for ethics approval [1] 306523 0
22/05/2020
Approval date [1] 306523 0
09/07/2020
Ethics approval number [1] 306523 0

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

Contacts
Principal investigator
Name 104158 0
Prof Peter Clifton
Address 104158 0
Level 1 room P1-17 Playford Building University of South Australia
GPO Box 2471 Adelaide SA 5001 Australia
Country 104158 0
Australia
Phone 104158 0
+61 403197998
Fax 104158 0
Email 104158 0
peter.clifton@unisa.edu.au
Contact person for public queries
Name 104159 0
Jennifer Keogh
Address 104159 0
Level 1 room P1-23, Playford Building City East Campus , University of South Australia
GPO Box 2471 Adelaide SA 5001 Australia
Country 104159 0
Australia
Phone 104159 0
+61883022579
Fax 104159 0
Email 104159 0
jennifer.keogh@unisa.edu.au
Contact person for scientific queries
Name 104160 0
Peter Clifton
Address 104160 0
Level 1 room P1-17 Playford Building University of South Australia
GPO Box 2471 Adelaide SA 5001 Australia
Country 104160 0
Australia
Phone 104160 0
+61 403197998
Fax 104160 0
Email 104160 0
peter.clifton@unisa.edu.au

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.