Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000279527
Ethics application status
Approved
Date submitted
25/02/2015
Date registered
25/03/2015
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results information initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of sweetener type on acute glucose and triglyceride responses
Scientific title
Effect of sweetener type on acute glucose and triglyceride responses in healthy adults as assessed by meal tolerance tests
Secondary ID [1] 286259 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 294313 0
Condition category
Condition code
Diet and Nutrition 294640 294640 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 acute crossover interventions with 3 muffins per visit will be consumed at 8am over 15 minutes after a 12 hour fast. A cup of tea or coffee can be consumed with the snack as long as it is consumed in the same way for each test. Each muffin is 100g (raw weight) and each test meal contains 3 muffins. The three sweeteners used are Sugar (63g), Fructose (51g) and Splenda (6g). The test meal containing sucrose also includes 32g cream (35% fat) and the meal containing fructose includes 24g of cream in order to standardise the fat content. All three test meals contain 66g fat. Energy content of the Sugar meal is 4.7MJ; the Fructose meal is 4.6 MJ and the Splenda meal is 4.1MJ. Total carbohydrate is 119g for the Sugar meal, 109g for the Fructose meal and 80g for the Splenda meal.
Each test will be repeated at weekly intervals and the usual diet will be continued between tests.
An indwelling cannula will be inserted and remain for the 4 hours of the test. Blood samples will be taken at 0,30,60,90,120,150,180,210 and 240 minutes. Blood samples will be used to measure glucose, triglyceride, free fatty acids (measured on the Konelab) and the inflammatory
markers IL1, IL6 and CRP (measured by ELISA).
Intervention code [1] 291275 0
Lifestyle
Comparator / control treatment
Healthy participants - all participants have all three meals. The three sweeteners are being compared to each other in this study and there is not a separate control meal.
Control group
Active

Outcomes
Primary outcome [1] 294402 0
Blood samples will be used to measure glucose, triglyceride, and free fatty acids (measured on Konelab). These tests comprise the primary outcome.
Timepoint [1] 294402 0
Blood samples will be taken fasting and 30, 60, 90, 120, 150, 180,210 and 240 minutes after each test meal
Secondary outcome [1] 313206 0
inflammatory markers IL1, IL6 and CRP (measured by ELISA). Inflammatory markers comprise the secondary outcome.
Timepoint [1] 313206 0
Blood samples will be taken fasting and at 30,60, 90, 120, 150, 180, 210 and 240 minutes after each test meal

Eligibility
Key inclusion criteria
Healthy men and women.
BMI 19 - 40.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Type 2 Diabetes

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Diet order will be randomised using a computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2015
Actual
30/03/2015
Date of last participant enrolment
Anticipated
Actual
15/05/2015
Date of last data collection
Anticipated
Actual
31/08/2015
Sample size
Target
24
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290818 0
University
Name [1] 290818 0
University of South Australia
Country [1] 290818 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
North Terrace and Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 289504 0
None
Name [1] 289504 0
None
Address [1] 289504 0
Country [1] 289504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304923 0
University of South Australia
Ethics committee address [1] 304923 0
GPO Box 2471, Adelaide, South Australia 5001
Ethics committee country [1] 304923 0
Australia
Date submitted for ethics approval [1] 304923 0
15/11/2014
Approval date [1] 304923 0
19/12/2014
Ethics approval number [1] 304923 0
0000033784

Summary
Brief summary
The aim of the research is to explore the interaction between different types of caloric and non caloric sweeteners in snack foods on glucose and triglyceride levels to see if there is an optimal sweetener. High levels of sugars and high fructose corn syrup in particular have been associated with weight gain and type 2 diabetes but it is not clear if it is the type of sweetener or just the increased caloric load that causes this effect. Current tests of the role of fructose use extremely high amounts that would not be found in normal food items. Biscuits, cakes and muffins all contain a much lower amount of fat and sugar, but contain wheat starch and components of food that will moderate the glycemic and triglyceridemic response such as fibre and protein. We need to know if changing the sweetener in this kind of snack alters the response of glucose and triglycerides.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55306 0
A/Prof Jennifer Keogh
Address 55306 0
University of South Australia PO BOX 2471 Adelaide SA 5000
Country 55306 0
Australia
Phone 55306 0
+61 8 8302 2579
Fax 55306 0
Email 55306 0
[email protected]
Contact person for public queries
Name 55307 0
A/Prof Jennifer Keogh
Address 55307 0
University of South Australia PO BOX 2471 Adelaide SA 5000
Country 55307 0
Australia
Phone 55307 0
+61 8 8302 2579
Fax 55307 0
Email 55307 0
[email protected]
Contact person for scientific queries
Name 55308 0
A/Prof Jennifer Keogh
Address 55308 0
University of South Australia PO BOX 2471 Adelaide SA 5000
Country 55308 0
Australia
Phone 55308 0
+61 8 8302 2579
Fax 55308 0
Email 55308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD data will be available as this was not approved by ethics.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFructose acute effects on glucose, insulin, and triglyceride after a solid meal compared with sucralose and sucrose in a randomized crossover study.2016https://dx.doi.org/10.3945/ajcn.115.129866
N.B. These documents automatically identified may not have been verified by the study sponsor.