Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000104257
Ethics application status
Approved
Date submitted
30/11/2017
Date registered
23/01/2018
Date last updated
16/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of artificial sweeteners on blood glucose control
Scientific title
Effect of non-nutritional sweeteners on glucose tolerance and pancreatic function of normal weight and overweight men and women
Secondary ID [1] 293503 0
None
Universal Trial Number (UTN)
U1111-1206-0570
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 305688 0
glucose intolerance 305689 0
Condition category
Condition code
Metabolic and Endocrine 304911 304911 0 0
Diabetes
Diet and Nutrition 305023 305023 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
500ml/day of artificially sweetened beverages containing aspartame (211mg/L) and acesulphame K (144mg/L) for 2 weeks.
Compliance will be assed by returned empty bottles
Washout will be 4 weeks
Intervention code [1] 299740 0
Lifestyle
Comparator / control treatment
500ml/day of unsweetened soda or mineral water (provided to volunteers) for 2 weeks - with any pattern of consumption over the day ie could be all at once or with meals or between meals..
Returned product and a checklist will be used to ensure compliance.
Control group
Active

Outcomes
Primary outcome [1] 304104 0
2 week average interstitial glucose measured by Abbott freestyle glucose monitor
Timepoint [1] 304104 0
end 2 weeks
Primary outcome [2] 304105 0
75g oral glucose tolerance glucose at 1 and 2 hrs between baseline and 2 weeks. The primary endpoints will be 2 hour glucose by serum assay
Timepoint [2] 304105 0
time 0 and 2 week on each treatment. The primary comparison will be the difference between week 0 and week 2 on each. treatment. This will be assessed by 2 week repeated measures ANOVA
Primary outcome [3] 304490 0
Insulin during OGTT at 1 and 2 hours. Measured by serum analysis
Timepoint [3] 304490 0
week 0 and week 2 on each treatment. The primary comparison will be the difference between week 0 and week 2 on each. treatment. This will be assessed by 2 week repeated measures ANOVA
Secondary outcome [1] 340997 0
Area under curve for glucose after 75g glucose at time zero and 2 week on each treatment. serum assay
Timepoint [1] 340997 0
baseline and week 2 on each treatment over time 0, 1 hour and 2 hours
Secondary outcome [2] 342016 0
C peptide release after 75g OGTT. serum assay.
Timepoint [2] 342016 0
week 0 and week 2 on each treatment at baseline, 1 and 2 hour

Eligibility
Key inclusion criteria
No known diabetes or pre diabetes
Normal weight volunteers BMI 18-25
Overweight/obese volunteers BMI>25
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
To be included volunteers must have no use at all of artificial sweeteners in the last 6 months

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
4 weeks washout
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Repeated measures ANOVA
20 normal weight volunteers and 20 overweight and obese volunteers. Based on Suez et al 2014 assuming an effect size 0.3 in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
Date of last participant enrolment
Anticipated
1/06/2018
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 18204 0
5000 - Adelaide Bc

Funding & Sponsors
Funding source category [1] 298123 0
University
Name [1] 298123 0
University of South Australia
Country [1] 298123 0
Australia
Primary sponsor type
University
Name
University of SA
Address
PO Box 2471 Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 297203 0
None
Name [1] 297203 0
Address [1] 297203 0
Country [1] 297203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299140 0
University of South Australia
Ethics committee address [1] 299140 0
University of SA Ethics Committee PO Box 2471 Adelaide South Australia 5000
Ethics committee country [1] 299140 0
Australia
Date submitted for ethics approval [1] 299140 0
30/11/2017
Approval date [1] 299140 0
15/03/2018
Ethics approval number [1] 299140 0
(Application ID: 200757)

Summary
Brief summary
There is some evidence that artificial sweeteners are associated with an increased risk of type 2 diabetes and in some studies this risk is greater in normal weight people. Clinical trials have not shown a definite increase in risk but a small study has shown that saccharin increases glucose intolerance in 4 days in half of the people studied. A second study showed that sucralose and AceK increased glucose absorption by 25-30%. We aim to investigate 2 weeks of usual artificial sweetener intake and measure 24 hour glucose levels over 2 weeks in response to normal foods and glucose, insulin and c peptide response to 75g of glucose before and after exposure to the sweetener and the control drink. We will examine normal weight and overweight men and women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79434 0
Prof Peter Clifton
Address 79434 0
School of Pharmacy and Medical Sciences , University of SA, PO Box 2471 Adelaide SA 5000
Country 79434 0
Australia
Phone 79434 0
+61403197998
Fax 79434 0
Email 79434 0
[email protected]
Contact person for public queries
Name 79435 0
Prof Peter Clifton
Address 79435 0
School of Pharmacy and Medical Sciences , University of SA, PO Box 2471 Adelaide SA 5000
Country 79435 0
Australia
Phone 79435 0
+61403197998
Fax 79435 0
Email 79435 0
[email protected]
Contact person for scientific queries
Name 79436 0
Prof Peter Clifton
Address 79436 0
School of Pharmacy and Medical Sciences , University of SA, PO Box 2471 Adelaide SA 5000
Country 79436 0
Australia
Phone 79436 0
+61403197998
Fax 79436 0
Email 79436 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4068Plain language summaryNo No effect of artificial sweeteners on glucose home... [More Details]
4686Study results articleYes Int J Environ Res Public Health 2020 Dec 4;17(23)... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseConsumption of a beverage containing aspartame and acesulfame K for two weeks does not adversely influence glucose metabolism in adult males and females: A randomized crossover study.2020https://dx.doi.org/10.3390/ijerph17239049
N.B. These documents automatically identified may not have been verified by the study sponsor.