ANZCTR - Registration

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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]

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

glucose intolerance

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

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]

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]

2 week average interstitial glucose measured by Abbott freestyle glucose monitor

Timepoint [1]

end 2 weeks

Primary outcome [2]

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]

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]

Insulin during OGTT at 1 and 2 hours. Measured by serum analysis

Timepoint [3]

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]

Area under curve for glucose after 75g glucose at time zero and 2 week on each treatment. serum assay

Timepoint [1]

baseline and week 2 on each treatment over time 0, 1 hour and 2 hours

Secondary outcome [2]

C peptide release after 75g OGTT. serum assay.

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5000 - Adelaide Bc

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

PO Box 2471 Adelaide SA 5000

Country [1]

Australia

Primary sponsor type

University

Name

University of SA

Address

PO Box 2471 Adelaide SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia

Ethics committee address [1]

University of SA Ethics Committee PO Box 2471 Adelaide  South Australia 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/11/2017

Approval date [1]

15/03/2018

Ethics approval number [1]

(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

Prof Peter Clifton

Address

School of Pharmacy and Medical Sciences , University of SA, PO Box 2471 Adelaide SA 5000

Country

Australia

Phone

+61403197998

Fax

peter.clifton@unisa.edu.au

Contact person for public queries

Name

Peter Clifton

Address

School of Pharmacy and Medical Sciences , University of SA, PO Box 2471 Adelaide SA 5000

Country

Australia

Phone

+61403197998

Fax

peter.clifton@unisa.edu.au

Contact person for scientific queries

Name

Peter Clifton

Address

School of Pharmacy and Medical Sciences , University of SA, PO Box 2471 Adelaide SA 5000

Country

Australia

Phone

+61403197998

Fax

peter.clifton@unisa.edu.au

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		No effect of artificial sweeteners on glucose home... [More Details]
Study results article	Yes		Int J Environ Res Public Health 2020 Dec 4;17(23)... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Consumption 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.	2020	https://dx.doi.org/10.3390/ijerph17239049

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically