Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000912886
Ethics application status
Approved
Date submitted
27/08/2012
Date registered
28/08/2012
Date last updated
7/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of a high protein/high soluble fibre drink on blood glucose
Scientific title
Impact of a high protein / high soluble fibre drink on blood glucose in type 2 diabetes
Secondary ID [1] 281095 0
Nil
Universal Trial Number (UTN)
U1111-1133-8381
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 287252 0
Condition category
Condition code
Metabolic and Endocrine 287576 287576 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial aims to show that a drink containing protein and a mix of protein and soluble fibre (guar) slows starch hydrolysis and absorption of glucose.

On each of the 4 test days participants will attend the research centre at 9am having fasted overnight for 12 hours. On the first test day a continuous glucose monitor will be inserted. It will remain in place for 5 days and calibrated daily using fingerprick glucoses 4 times/day.

On each test day participants will be fed a morning meal consisting of 4 slices of white bread (50g of carbohydrate) with 5g jam on each slice. No fat topping will be provided. On two occasions the bread and jam will be preceeded by 150ml of water (control) and on the other 2 occasions preceeded by a 150ml drink containing 20g protein plus 5 g guar (treatment). The drink (control or treatment) will be taken 15 minutes before consuming the bread and jam.

The tests will be performed across four consecutive days with 12 volunteers, with the first two days randomised to treatment or control, and the second two days randomised to treatment or control.
Intervention code [1] 285547 0
Treatment: Other
Intervention code [2] 285548 0
Lifestyle
Comparator / control treatment
150 ml of water will be given as a control prior to the bread and jam in place of the treatment drink.
Control group
Placebo

Outcomes
Primary outcome [1] 287837 0
Mean reduction in post-prandial blood glucose levels (mmol)
Timepoint [1] 287837 0
Within the 24 h following morning test meal during intervention period
Secondary outcome [1] 298908 0
Nil
Timepoint [1] 298908 0
Nil

Eligibility
Key inclusion criteria
Diagnosed with type 2 diabetes
On oral hypoglycemic medication
HbA1c reading of >7.0% within the last 6 months
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or lactating women
Previous bariatric surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Both the researcher who determined if the subject was eligible for inclusion in the trial, and the subject, were not aware if the subject would be allocated to the treatment or the control on a given day. Allocation was centrally performed by computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285881 0
Government body
Name [1] 285881 0
Commercialisation Australia
Country [1] 285881 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Omniblend
Address
4 - 8 Capital Link Drive
Campbellfield, VIC 3061
Country
Australia
Secondary sponsor category [1] 284706 0
Charities/Societies/Foundations
Name [1] 284706 0
Baker IDI Heart & Diabetes Institute
Address [1] 284706 0
75 Commercial Rd
Prahran
VIC 3181
Country [1] 284706 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287909 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 287909 0
Ethics committee country [1] 287909 0
Australia
Date submitted for ethics approval [1] 287909 0
Approval date [1] 287909 0
09/11/2011
Ethics approval number [1] 287909 0
367.11

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

Contacts
Principal investigator
Name 34621 0
Address 34621 0
Country 34621 0
Phone 34621 0
Fax 34621 0
Email 34621 0
Contact person for public queries
Name 17868 0
Prof Peter Clifton
Address 17868 0
GPO Box 664 Adelaide SA 5001
Country 17868 0
Australia
Phone 17868 0
+61884629702
Fax 17868 0
Email 17868 0
[email protected]
Contact person for scientific queries
Name 8796 0
Prof Peter Clifton
Address 8796 0
GPO Box 664 Adelaide SA 5001
Country 8796 0
Australia
Phone 8796 0
+61884629702
Fax 8796 0
Email 8796 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
No additional documents have been identified.