Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000375257
Ethics application status
Approved
Date submitted
12/03/2009
Date registered
28/05/2009
Date last updated
12/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of dietary fibre and protein from lupin on blood glucose in type 2 diabetes
Scientific title
The effect of dietary fibre and protein from lupin on blood glucose in type 2 diabetes
Secondary ID [1] 288290 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 4469 0
Condition category
Condition code
Metabolic and Endocrine 4741 4741 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A study of the acute effects of dietary fibre and protein from legumes (when added to drinks) on blood glucose and insulin levels will be assessed. Three treatments, administered in random order at least 1 week apart, will be compared – 1) lupin flour high in protein and fibre [50 g of flour containing 22 g protein and 12.5 g fibre], plus 50 g glucose; 2) Soy protein [22 g] and fibre [12.5 g] provided as a mixture of isolated soy protein and concentrated soy fibre, plus 50 g glucose; 3) 50 g glucose (carbohydrate-matched control). Each treatment will be consumed as a 600 ml beverage, consumed over a 15 minute time period. Each treatment corresponds to a single clinic visit lasting 5 hours. Participants attend the clinic after a 12 hour overnight fast. A venous cannula will be inserted in the antecubital fossa vein and after a 15 minute rest baseline blood samples will be drawn. The treatment beverage is consumed, then blood samples are taken every 15 minutes for 1 hour, then every 30 minutes to 2 hours and then hourly to 4 hours.
Intervention code [1] 4213 0
Treatment: Other
Comparator / control treatment
The total energy-matched control will be used to assess post-treatment effects of lupin or soy on appetite.

The carbohydrate-matched control will be used to assess post-treatment effects of lupin and soy on glucose and insulin responses.
Control group
Placebo

Outcomes
Primary outcome [1] 5607 0
Plasma glucose concnetrations assessed using routine biochemical techniques performed in an accredited pathology laboratory
Timepoint [1] 5607 0
During the 4 hours post treatment
Primary outcome [2] 5608 0
Plasma insulin concnetrations assessed using routine biochemical techniques performed in an accredited pathology laboratory
Timepoint [2] 5608 0
During the 4 hours post treatment
Secondary outcome [1] 9439 0
Incretin hormones including glucagon-like peptide-1 (GLP-1) assessed using a commercially available assay
Timepoint [1] 9439 0
During the 4 hours post treatment

Eligibility
Key inclusion criteria
Diagnosis of type 2 diabetes within the previous 10 years (confirmed by a general practitioner, or evident at screening with fasting glucose > 7 mmol/L); age 35-65 years; body mass index < 40kg/m2; glycated haemoglobin < 9%.
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes, insulin use, >10% change in body weight in previous 6 months, smoking currently or within the last 6 months, daily alcohol consumption >3 standard drinks for females and >4 standard drinks for males, known allergy to lupin/nuts/soy/dairy/wheat/ gluten, other major chronic illness, change in regular medications in previous 3 months.

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)
The order in which participants receive the treatments will be randomly assigned using computer generated random numbers. The sequence allocation will be sealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence of random numbers
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
5/05/2009
Actual
5/05/2009
Date of last participant enrolment
Anticipated
30/06/2010
Actual
30/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4660 0
Government body
Name [1] 4660 0
Department of Industry and Resources, State Government of Western Australia
Country [1] 4660 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Stirling Hwy
Crawley
WA 6009
Country
Australia
Secondary sponsor category [1] 4205 0
None
Name [1] 4205 0
Address [1] 4205 0
Country [1] 4205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239130 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 239130 0
Ethics committee country [1] 239130 0
Australia
Date submitted for ethics approval [1] 239130 0
Approval date [1] 239130 0
04/05/2009
Ethics approval number [1] 239130 0
2008/185

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

Contacts
Principal investigator
Name 29390 0
A/Prof Jonathan Hodgson
Address 29390 0
GPO Box X2213 Perth WA 6847
Country 29390 0
Australia
Phone 29390 0
61 8 9224 0267
Fax 29390 0
Email 29390 0
[email protected]
Contact person for public queries
Name 12637 0
Dr Emma Dove
Address 12637 0
School of Medicine & Pharmacology
Medical Research Foundation Building
Level 3, Rear 50 Murray Street
PERTH Western Australia 6000
Country 12637 0
Australia
Phone 12637 0
+61 8 9224 0341
Fax 12637 0
Email 12637 0
[email protected]
Contact person for scientific queries
Name 3565 0
Dr Emma Dove
Address 3565 0
School of Medicine & Pharmacology
Medical Research Foundation Building
Level 3, Rear 50 Murray Street
PERTH Western Australia 6000
Country 3565 0
Australia
Phone 3565 0
+61 8 9224 0341
Fax 3565 0
Email 3565 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.