ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

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]

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]

Blood samples will be used to measure glucose, triglyceride, and free fatty acids (measured on Konelab). These tests comprise the primary outcome.

Timepoint [1]

Blood samples will be taken fasting and 30, 60, 90, 120, 150, 180,210 and 240 minutes after each test meal

Secondary outcome [1]

inflammatory markers IL1, IL6 and CRP (measured by ELISA). Inflammatory markers comprise the secondary outcome.

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

City East Campus
North Terrace and Frome Road
Adelaide SA 5000

Country [1]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia

Ethics committee address [1]

GPO Box 2471, Adelaide, South Australia 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/11/2014

Approval date [1]

19/12/2014

Ethics approval number [1]

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

A/Prof Jennifer Keogh

Address

University of South Australia PO BOX 2471 Adelaide SA 5000

Country

Australia

Phone

+61 8 8302 2579

Fax

jennifer.keogh@unisa.edu.au

Contact person for public queries

Name

Jennifer Keogh

Address

University of South Australia PO BOX 2471 Adelaide SA 5000

Country

Australia

Phone

+61 8 8302 2579

Fax

jennifer.keogh@unisa.edu.au

Contact person for scientific queries

Name

Jennifer Keogh

Address

University of South Australia PO BOX 2471 Adelaide SA 5000

Country

Australia

Phone

+61 8 8302 2579

Fax

jennifer.keogh@unisa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Fructose acute effects on glucose, insulin, and triglyceride after a solid meal compared with sucralose and sucrose in a randomized crossover study.	2016	https://dx.doi.org/10.3945/ajcn.115.129866

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

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Documents added manually

Documents added automatically