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Trial registered on ANZCTR
Registration number
ACTRN12618001285246
Ethics application status
Approved
Date submitted
25/07/2018
Date registered
31/07/2018
Date last updated
16/04/2020
Date data sharing statement initially provided
26/04/2019
Date results information initially provided
26/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Is there a difference when whole grains are eaten whole vs. milled on the blood glucose control of people with type 2 diabetes?
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Scientific title
Role of wholegrain structure in the blood glucose control of people with type 2 diabetes as measured over two weeks by continuous glucose monitoring systems.
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Secondary ID [1]
295655
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None
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Universal Trial Number (UTN)
U1111-1218-0678
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The blood glucose control of people with type 2 diabetes
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Condition category
Condition code
Metabolic and Endocrine
307895
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A two week exposure where wholegrain foods will be provided to participants, where the whole grains are largely intact, which is to say minimally processed. Examples are whole oats, a wholegrain bread with intact grains, and brown rice. Participants completed a pre study four-day dietary record (4DDR) to measure the number of grain serves consumed per day, and were asked to continue consuming that amount from the foods we provided. Adherence with this guideline will be monitored for the two weeks of the intervention with a daily check list, and with a four day diet record during each two-week exposure. There is a two-week wash out period between the interventions.
Blood glucose control will be measured with a continuous glucose monitoring system for the two-week intervention. Participants will receive instructions of how to maintain the device inline with manufacturer recommendations. Previous research by this research group on 41 participants over two interventions did not result in any adverse events due to the use of these devices.
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Intervention code [1]
301974
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Lifestyle
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Comparator / control treatment
A two week exposure where wholegrain foods will be provided to participants, where the whole grains are milled or ground down. Examples are instant oats, a wholegrain bread with finely milled flour, and an extruded pasta made with brown rice. Participants completed a pre study 4DDR to measure the number of grain serves consumed per day, and were asked to continue consuming that amount from the foods we provided. Adherence with this guideline will be monitored for the two weeks of the intervention with a daily check list, and with a three day diet record during each two-week exposure. There is a two-week wash out period between the interventions.
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Control group
Active
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Outcomes
Primary outcome [1]
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Blood glucose control as measured by: fasting blood glucose, mean blood glucose, postprandial blood glucose, time spent over 8mmol/L, and measures of glycaemic variability.
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Assessment method [1]
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Timepoint [1]
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Primary outcome data are obtained from a continuous glucose monitoring system worn for the two weeks of each intervention.
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Secondary outcome [1]
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Palatability of the provided foods will be measured by visual analogue scales (10cm).
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Assessment method [1]
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Timepoint [1]
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Collected during each two week intervention on a three day food diary of two week days and one weekend day. These days will occur in the second week of each intervention where the days are specified inline with a computer generated randomisation protocol.
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Secondary outcome [2]
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Change in circulating total cholesterol.
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Assessment method [2]
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Timepoint [2]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Secondary outcome [3]
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Difference in dental plaque on teeth between interventions. This is measured by scoring participants mouths after they have chewed a vegetable dye tablet that stains acid producing plaque. Six indicator teeth are scored from 0 (no plaque) to 3 (more than 2/3 of the teeth surface covered).
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Assessment method [3]
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Timepoint [3]
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Measured pre and post each intervention.
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Secondary outcome [4]
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Change in body weight (kg).
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Assessment method [4]
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Timepoint [4]
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Measured pre and post each intervention.
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Secondary outcome [5]
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Small organic molecule profile of exhaled breath during carbohydrate digestion as measured by mass spectroscopy.
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Assessment method [5]
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Timepoint [5]
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We will measure the exhaled gas profile of participants pre and post each intervention. Participants are required to breathe three normal breaths near a sensor.
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Secondary outcome [6]
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Participant satiety due to the provided foods will be measured by visual analogue scales (10cm) throughout the days they complete their three day food diary.
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Assessment method [6]
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Timepoint [6]
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Collected during each two week intervention on a three day food diary of two week days and one weekend day. These days will occur in the second week of each intervention where the days are specified inline with a computer generated randomisation protocol.
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Secondary outcome [7]
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Change in circulating LDL cholesterol.
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Assessment method [7]
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Timepoint [7]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Secondary outcome [8]
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Change in circulating HDL cholesterol.
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Assessment method [8]
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Timepoint [8]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Secondary outcome [9]
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Change in circulating triglycerides.
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Assessment method [9]
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Timepoint [9]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Secondary outcome [10]
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Change in circulating C-reactive protein.
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Assessment method [10]
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Timepoint [10]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Secondary outcome [11]
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Change in body mass index (BMI).
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Assessment method [11]
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Timepoint [11]
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Measured pre and post each intervention.
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Secondary outcome [12]
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Change in fatmass via bioelectrical impedance.
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Assessment method [12]
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Timepoint [12]
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Measured pre and post each intervention.
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Secondary outcome [13]
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Change in circulating tumour necrosis factor alpha (TNF-a).
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Assessment method [13]
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Timepoint [13]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Secondary outcome [14]
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Change in circulating alkylresorcinols.
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Assessment method [14]
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Timepoint [14]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Secondary outcome [15]
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Change in circulating Interleukins as a marker of systemic inflammation.
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Assessment method [15]
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Timepoint [15]
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A fasted venous blood sample taken at the start and end of each two week intervention.
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Eligibility
Key inclusion criteria
Diagnosed with type 2 diabetes.
Have not changed prescribed medicine dose or type in the last three months
Willing to comply with study requirements of consuming whole grains each day.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
pregnant or lactating.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Staff administering the study will not be able to access the sequentially numbered, opaque, sealed envelopes that state the order of interventions until after a participant has provided written informed consent and is ready to start an intervention.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based randomisation process.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
Randomisation process will be balanced between the two interventions.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The sample size estimate was based on a power calculation with an alpha of 0.05 and power of 0.80 to detect within-group differences in primary outcome variable, a clinically relevant 20 % difference in postprandial glycaemia as measured by CGM. From this calculation we required 28 participants to complete both interventions,
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/08/2018
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Actual
8/10/2018
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Date of last participant enrolment
Anticipated
1/04/2019
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Actual
1/04/2019
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Date of last data collection
Anticipated
18/05/2019
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Actual
18/05/2019
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Sample size
Target
28
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Accrual to date
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Final
28
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Department of Medicine, University of Otago
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Address [1]
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Department of Medicine
PO BOX 56
Dunedin 9010 Otago
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Country [1]
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New Zealand
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Laurenson Award
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Address [2]
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Otago Medical Research Foundation
PO Box 5726
Dunedin NEW ZEALAND 9058
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Country [2]
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New Zealand
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Funding source category [3]
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University
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Name [3]
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Riddet Institute
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Address [3]
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Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
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Country [3]
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
PO BOX 56
Dunedin 9010 Otago
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
299657
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301061
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Health and Disability Ethics Committees
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Ethics committee address [1]
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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03/08/2018
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Approval date [1]
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03/09/2018
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Ethics approval number [1]
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Summary
Brief summary
Last year we measured the difference in acute blood glucose response due to food where whole grains were either intact, or ground down (ACTRN12617000328370). The differences we observed in blood glucose from these meal responses warrants further investigation, to see if the structural integrity of whole grains may play a role in the longer-term blood glucose control of people with type 2 diabetes.
This new trial therefore looks at blood glucose control in two, two-week interventions. We would like the same people to do both interventions, with a two-week break in between the interventions. In one intervention, we will provide participants with whole grain products that are largely intact (whole oats, bread with whole grains baked in, and brown rice) and ask them to replace their grain servings each day with the foods we provide. In the other intervention we will provide whole grain products that have been milled (instant oats, wholemeal bread, pasta made from brown rice) and ask them to replace their grain servings each day with the foods we provide. Each participant will be randomised to the order they do the interventions in. We would like 28 or more participants to complete both interventions. During each intervention participant's blood glucose control will be measured with continuous blood glucose monitors. We will primarily compare participants blood glucose control with these devices between interventions, but we will also consider possible differences in participant satiety, cholesterol and other blood markers, the level of acid forming plaque on their teeth, and measures of body weight and body fatness.
Our hypothesis is that the structural integrity of the wholegrain is a necessary parameter of why whole grains have been identified as beneficial in both prospective and intervention studies. Removing the structural integrity of whole grains therefore, will reduce the beneficial response. We are particularly interested in blood glucose control, but will also measure blood lipids and inflammation to see if the structural integrity of whole grains might also influence these other cardiometabolic markers.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Andrew Reynolds
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Address
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Department of Medicine
University of Otago
PO Box 56
Dunedin 9010 Otago
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Country
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New Zealand
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Phone
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+64279565826
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Andrew Reynolds
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Address
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Department of Medicine
University of Otago
PO Box 56
Dunedin 9010 Otago
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Country
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New Zealand
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Phone
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+64279565826
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Andrew Reynolds
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Address
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Department of Medicine
University of Otago
PO Box 56
Dunedin 9010 Otago
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Country
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New Zealand
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Phone
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+64279565826
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No potentially identifiable data - such as individual patient data - will be released.
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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.
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