Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000125224
Ethics application status
Approved
Date submitted
1/12/2017
Date registered
29/01/2018
Date last updated
29/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of fructose in muffins on short term and long term glucose and lipid control
Scientific title
Effect of fructose in muffins on short term and long term glucose and lipid control in non-diabetic individuals with a BMI>30
Secondary ID [1] 293505 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 305690 0
Condition category
Condition code
Metabolic and Endocrine 304912 304912 0 0
Diabetes
Metabolic and Endocrine 305296 305296 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 X80g high fat muffins (30% fat) containing 21g sucrose per muffin then 2 X80g high fat muffins (30% fat) containing 21g fructose per muffin (in random order one week apart) in 2 acute studies (3 hour study with blood samples taken at baseline, 30,60.90,120,150 and 180 minutes) immediately followed by 4 weeks of 2 X80g low fat muffins (15% fat)/daily containing 21g fructose per muffin followed immediately by a repeat of the two acute studies.
Compliance assessed by checklist and frozen muffin return.
Intervention code [1] 299741 0
Lifestyle
Comparator / control treatment
The comparator/control are the 2 X80g low fat muffins (15% fat) containing 21g sucrose per muffin consumed daily for 4 weeks by the control participants. The acute tests are the same for both intervention and control.
Compliance assessed by checklist and frozen muffin return.
Control group
Active

Outcomes
Primary outcome [1] 304106 0
Triglyceride level by serum assay
Timepoint [1] 304106 0
The acute tests for the fructose muffins and the sucrose muffins are from 0-3 hours at time points 0, 30, 60, 90, 120, 150, 180. immediately before and immediately after the 4 week chronic consumption period. Significance assessed across all time points together
Secondary outcome [1] 340998 0
Body Weight as measured in the clinic by the clinic staff
Timepoint [1] 340998 0
at baseline and at 4 weeks from initial muffin consumption ie after 4 weeks of additional daily muffins.
Secondary outcome [2] 342017 0
Glucose by serum assay
Timepoint [2] 342017 0
The acute tests for the fructose muffins and the sucrose muffins are from 0-3 hours at time points 0, 30, 60, 90, 120, 150, 180. immediately before and immediately after the 4 week chronic consumption period. Significance assessed across all time points together

Eligibility
Key inclusion criteria
Overweight or obese BMI>25
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 to chronic muffin determined by an administrative person
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
order of acute studies, type of chronic muffin and order of second acute studies using random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
All treatments were delivered to all people in the acute study. For the chronic muffin consumption the design was parallel only.
Phase
Type of endpoint/s
Statistical methods / analysis
Repeated measures ANOVA with time (0-180 minutes and baseline or 1 month) as repeated measures and acute treatment allocation and chronic muffin allocation as factors

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/02/2016
Date of last participant enrolment
Anticipated
Actual
1/06/2016
Date of last data collection
Anticipated
Actual
4/07/2016
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 18205 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298124 0
University
Name [1] 298124 0
University of South Australia
Country [1] 298124 0
Australia
Primary sponsor type
University
Name
university of SA
Address
Po Box 2471 Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 297204 0
None
Name [1] 297204 0
Address [1] 297204 0
Country [1] 297204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299141 0
University of South Australia
Ethics committee address [1] 299141 0
Ethics committee country [1] 299141 0
Australia
Date submitted for ethics approval [1] 299141 0
01/12/2015
Approval date [1] 299141 0
02/12/2015
Ethics approval number [1] 299141 0
038874

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

Contacts
Principal investigator
Name 79438 0
Prof Peter Clifton
Address 79438 0
School of Pharmacy and Medical Sciences University of SA PO Box 2471 Adelaide SA 5000
Country 79438 0
Australia
Phone 79438 0
+61403197998
Fax 79438 0
Email 79438 0
[email protected]
Contact person for public queries
Name 79439 0
Peter Clifton
Address 79439 0
School of Pharmacy and Medical Sciences University of SA PO Box 2471 Adelaide SA 5000
Country 79439 0
Australia
Phone 79439 0
+61403197998
Fax 79439 0
Email 79439 0
[email protected]
Contact person for scientific queries
Name 79440 0
Peter Clifton
Address 79440 0
School of Pharmacy and Medical Sciences University of SA PO Box 2471 Adelaide SA 5000
Country 79440 0
Australia
Phone 79440 0
+61403197998
Fax 79440 0
Email 79440 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
No documents have been uploaded by study researchers.

Documents added automatically
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