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Trial registered on ANZCTR


Registration number
ACTRN12615000297527
Ethics application status
Approved
Date submitted
16/03/2015
Date registered
31/03/2015
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of lupin-containing foods on blood sugar levels and blood pressure in type 2 diabetes
Scientific title
Effects of lupin-containing foods on blood sugar levels and blood pressure in type 2 diabetes
Secondary ID [1] 286361 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 294495 0
high blood pressure 294496 0
Condition category
Condition code
Metabolic and Endocrine 294799 294799 0 0
Diabetes
Cardiovascular 294800 294800 0 0
Hypertension
Mental Health 294801 294801 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, controlled, cross-over designed trial will be performed to investigate the short-term effects of regular consumption of lupin-containing food (bread, breakfast cereral, pasta and crumbs) on glycaemic control (primary outcome), blood pressure, attention and working memory in type 2 diabetic individuals. A study coordinator and research nurse with experience in the conduct of similar nutrition intervention studies will be responsible for the conduct of the study.

Participants will be randomly assigned with the use of computer-generated random numbers to 1 of 2 groups: control then lupin or lupin then control. Both lupin and control participants will be required to replace ~15–20% of their usual daily energy intake from wheat-based products, with either control or lupin foods, for 8 weeks each. The two 8-week intervention periods will be separated by an 8-week washout period where participants return to their usual diet. Throughout the entire study period alcohol intake, physical activity and medication will be maintained as usual.

The food, for both the lupin and control foods will be provided. Compliance to diets will be monitored using questionnaires and return of unused foods at biweekly study visits. With the inclusion of several lupin enriched foods and matching control foods, there will be only minor changes to the make-up of the diet (the types of foods consumed).
Intervention code [1] 291422 0
Treatment: Other
Intervention code [2] 291453 0
Lifestyle
Comparator / control treatment
Foods matched to the lupin-enriched foods containing higher levels of carbohydrate derived from wheat and lower levels of protein and fibre.
Control group
Active

Outcomes
Primary outcome [1] 294551 0
Home-measured blood glucose concentrations
Timepoint [1] 294551 0
All participants will be provided with their own home blood glucose monitor. The home blood glucose monitoring will be performed 4 times per day, on 3 days per week (2 weekdays and 1 weekend day) over each 8 week intervention period of the study. The times of day for measuring blood glucose are as specified: fasting upon waking; 1 h post breakfast; immediately before lunch; and 1 h after lunch. In addition, self-monitoring of blood glucose will be performed in the week leading up to each 8-week intervention period (baseline).
Secondary outcome [1] 313603 0
Home-monitored blood pressure
Timepoint [1] 313603 0
Participants will be provided with home blood pressure monitors to measure their blood pressure on 3 days per week (2 weekdays and 1 weekend day) during each 8 week intervention period of the study. Participants will measure their blood pressure twice daily on the same days they are required to measure their blood glucose. The first set of readings will be taken approximately 30 mins after waking, but before breakfast. The second set of readings will be taken at the end of the day, just prior to going to bed. Participants will be seated alone in a quiet room where possible. They will then perform 5 blood pressure measurements over a 5 minute period. The first measurement will not be used for analysis. To minimize bias all blood pressure measurements will be stored by the home blood pressure monitor, then downloaded by the study coordinator at biweekly visits. In addition, blood pressure measurements will be performed in the week leading up to the start of each 8-week intervention period (baseline).
Secondary outcome [2] 313604 0
Fasting blood measures of glycated haemoglobin, glucose, insulin (and HOMA-IR score calculated from the fasting glucose and insulin)
Timepoint [2] 313604 0
All these measurements will be performed at week 0, 4, 8, 16, 20 and 24.
Secondary outcome [3] 313605 0
Pulse wave velocity measured using the Sphygmocor (AtCor Medical).
Timepoint [3] 313605 0
These measurements will be taken at weeks 0, 8, 16 and 24.
Secondary outcome [4] 313606 0
Cognitive function testing to assess the cognitive domains of attention and working memory
Timepoint [4] 313606 0
This will be assessed using the Computerised Mental Performance Assessment System (COMPASS) battery at week 0, 8, 16 and 24.
Secondary outcome [5] 313607 0
Bowel function assessed by a questionnaire designed for this study that gathers information about bowel health symptoms
Timepoint [5] 313607 0
Week 0, 8, 16 and 24.
Secondary outcome [6] 313608 0
Palatability/acceptability of foods measured using a food acceptability questionnaire designed for this study
Timepoint [6] 313608 0
Week 0, 8, 16 and 24.

Eligibility
Key inclusion criteria
Men and women 40 to 70 years old with moderate to well-controlled type 2 diabetes (glycated Hb < 9%) will be recruited from the general population. The diagnosis of diabetes will be confirmed by either a fasting serum glucose >7 mmol/l, the participant’s registration with the National Diabetes Services Scheme (which requires a medical diagnosis of diabetes), use of metformin, or confirmation from the participant’s general practitioner (with a review of relevant clinical data).
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include type 1 diabetes; duration of diabetes >10 years; use of insulin; glycated Hb >9%; change in body weight >10% in the previous 6 months; BMI > 35 kg/m2; cigarette use in the previous 6 months; daily ethanol consumption >20 g for females or >30 g for males; known allergy to lupin, nuts, soya, dairy, wheat or gluten; don’t regularly consume bread; other major chronic illness; change in regular prescription medications in the previous 3 months; estimated usual intake of bread and related wheat-based baked products of less than 100 g/d; and inability or unwillingness to follow the study protocol.

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 treatment order for eligible individuals will be randomly assigned using computer generated random numbers. The treatment order allocation will be sealed in numbered envelopes. The envelopes will be used for randomisation by opening an envelope, in consecutive order, as participants are entered into the study. The envelopes will be held by an independent person within the University of Western Australia. The study coordinator will contact the independent person to obtain the next available envelope once an individual is deemed eligible. The envelope will be opened and the code will be recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers using Microsoft Excel
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
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
16/04/2015
Actual
16/04/2015
Date of last participant enrolment
Anticipated
1/05/2017
Actual
22/05/2017
Date of last data collection
Anticipated
1/12/2017
Actual
22/11/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290931 0
Charities/Societies/Foundations
Name [1] 290931 0
Medical Research Foundation Royal Perth Hospital
Country [1] 290931 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009 Australia
Country
Australia
Secondary sponsor category [1] 289616 0
None
Name [1] 289616 0
Address [1] 289616 0
Country [1] 289616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292538 0
University of Western Australia Human Ethics Committee
Ethics committee address [1] 292538 0
Ethics committee country [1] 292538 0
Australia
Date submitted for ethics approval [1] 292538 0
Approval date [1] 292538 0
26/09/2014
Ethics approval number [1] 292538 0
RA/4/1/7070

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

Contacts
Principal investigator
Name 55806 0
A/Prof Jonathan Hodgson
Address 55806 0
UWA School of Medicine and Pharmacology, GPO Box X2213, Perth, WA 6847
Country 55806 0
Australia
Phone 55806 0
61 (0)8 9224 0267
Fax 55806 0
61 (0)8 9224 0246
Email 55806 0
jonathan.hodgson@uwa.edu.au
Contact person for public queries
Name 55807 0
Jonathan Hodgson
Address 55807 0
UWA School of Medicine and Pharmacology, GPO Box X2213, Perth, WA 6847
Country 55807 0
Australia
Phone 55807 0
61 (0)8 9224 0267
Fax 55807 0
61 (0)8 9224 0246
Email 55807 0
jonathan.hodgson@uwa.edu.au
Contact person for scientific queries
Name 55808 0
Jonathan Hodgson
Address 55808 0
UWA School of Medicine and Pharmacology, GPO Box X2213, Perth, WA 6847
Country 55808 0
Australia
Phone 55808 0
61 (0)8 9224 0267
Fax 55808 0
61 (0)8 9224 0246
Email 55808 0
jonathan.hodgson@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval for this.


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.