Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000060741
Ethics application status
Approved
Date submitted
24/12/2021
Date registered
20/01/2022
Date last updated
9/01/2023
Date data sharing statement initially provided
20/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Wholegrain structure in the blood glucose management of adults with type 2 diabetes
Scientific title
Wholegrain structure in the blood glucose management of adults with type 2 diabetes
Secondary ID [1] 306109 0
None
Universal Trial Number (UTN)
U1111-1268-7066
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 324782 0
Condition category
Condition code
Diet and Nutrition 322233 322233 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 322393 322393 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Unmilled wholegrain intervention: We will provide a free delivery of unmilled wholegrain foods delivered to the participants door each fortnight for 12 weeks. Examples are 1kg whole oats, five loaves of 700g wholegrain bread with intact grains, and 1kg brown rice. We will advice participants to replace the grain foods that they normally consume with the wholegrain foods provided. In line with New Zealand dietary guidelines we will not set a maximum number of serves of whole grain per day. There is no other lifestyle advice given. Intervention adherence will be assessed by Food Frequency Questionnaire, four day food diary, and alkylresorcinols as a metabolite measure of wholegrain intake from a dried blood spot pre and post intervention. All participants continue to receive usual care through their general practice during the study, which may include pharmacological and lifestyle management.
Intervention code [1] 322526 0
Lifestyle
Comparator / control treatment
Milled wholegrain intervention: We will provide a free delivery of milled wholegrain foods delivered to the participants door each fortnight for 12 weeks. Examples are 1kg instant oats, five loaves of 700g wholegrain bread with finely milled flour, and 1kg extruded pasta made with brown rice. We will advice participants to replace the grain foods that they normally consume with the wholegrain foods provided. In line with New Zealand dietary guidelines we will not set a maximum number of serves of whole grain per day. There is no other lifestyle advice given.Intervention adherence will be assessed by Food Frequency Questionnaire, four day food diary, and alkylresorcinols as a metabolite measure of wholegrain intake from a dried blood spot pre and post intervention. All participants continue to receive usual care through their general practice during the study, which may include pharmacological and lifestyle management.
Control group
Active

Outcomes
Primary outcome [1] 330008 0
Glycated haemoglobin (HbA1c)
Timepoint [1] 330008 0
Measured in fasting blood samples taken pre and post 12 week intervention.
Secondary outcome [1] 404570 0
Body weight (kg) - measured by health professional on fasted participant at time of blood draw, using Tanita body weight scales.
Timepoint [1] 404570 0
Measured at the same time as the fasting blood are samples taken pre and post 12 week intervention.
Secondary outcome [2] 404571 0
Body fat percentage by bioelectrical impedance analysis
Timepoint [2] 404571 0
Measured at the same time as the fasting blood are samples taken pre and post 12 week intervention.
Secondary outcome [3] 404572 0
Body Mass Index (BMI) - measured by health professional on fasted participant at time of blood draw, using Tanita body weight scales.
Timepoint [3] 404572 0
Measured at the same time as the fasting blood are samples taken pre and post 12 week intervention.
Secondary outcome [4] 404573 0
Blood cholesterol concentration: Total cholesterol
Timepoint [4] 404573 0
Measured in fasting blood samples taken pre and post 12 week intervention.
Secondary outcome [5] 404574 0
Blood cholesterol concentration: LDL cholesterol
Timepoint [5] 404574 0
Measured in fasting blood samples taken pre and post 12 week intervention.
Secondary outcome [6] 404575 0
Blood cholesterol concentration: HDL cholesterol
Timepoint [6] 404575 0
Measured in fasting blood samples taken pre and post 12 week intervention.
Secondary outcome [7] 404576 0
Blood triglyceride concentration
Timepoint [7] 404576 0
Measured in fasting blood samples taken pre and post 12 week intervention.
Secondary outcome [8] 404577 0
Fasting plasma glucose
Timepoint [8] 404577 0
Measured in fasting blood samples taken pre and post 12 week intervention.
Secondary outcome [9] 404578 0
C-reactive protein (CRP)
Timepoint [9] 404578 0
Measured in fasting blood samples taken pre and post 12 week intervention.

Eligibility
Key inclusion criteria
Participants will be aged 18-80 and have been diagnosed with type 2 diabetes. Participants must be willing to comply with the study requirement to replace the grain foods they eat with the provided wholegrain foods.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will have not changed prescribed diabetes medicine dose or type in the last three 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)
central randomisation by computer (built into REDCap online portal).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generation, stratified by insulin use (yes/no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We based an estimate of the sample size on a power calculation with an alpha of 0.05 and power of 0.80 to detect a between-group difference of 4.0 mmol/mol in glycated haemoglobin. We require 60 participants to complete each intervention. We intend to over-recruit to allow for drop out and better consider the secondary outcomes by enrolling 80 participants per intervention. Data will be analysed according to intention to treat. A mixed model will be used to analyse the data and consider potential interaction effects.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
15/04/2022
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
20/09/2023
Actual
Sample size
Target
160
Accrual to date
35
Final
Recruitment outside Australia
Country [1] 24463 0
New Zealand
State/province [1] 24463 0
Otago, Southland, and Canterbury

Funding & Sponsors
Funding source category [1] 310463 0
Charities/Societies/Foundations
Name [1] 310463 0
Lotteries Health Research
Country [1] 310463 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Research and Enterprise
PO Box 56
Dunedin. Otago. 9010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311612 0
None
Name [1] 311612 0
Address [1] 311612 0
Country [1] 311612 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310094 0
Health and Disability Ethics Committee
Ethics committee address [1] 310094 0
Ministry of Health
PO Box 5013
Wellington 6011
New Zealand
Ethics committee country [1] 310094 0
New Zealand
Date submitted for ethics approval [1] 310094 0
22/10/2021
Approval date [1] 310094 0
31/01/2022
Ethics approval number [1] 310094 0
21/STH/229

Summary
Brief summary
There is almost universal acceptance that appropriate nutrition is a pivotal component of attempts to reduce the burden of disease such as obesity, diabetes, cardiovascular disease and some cancers. Healthy eating also has the potential to help achieve equity of health outcomes amongst population groups where inequalities exist such as Maori and Pacific people in New Zealand. While some dietary advice is generally accepted, there is continuing debate regarding the amount and type of dietary carbohydrate.

There is convincing evidence that wholegrain consumption protects against colorectal cancer, type 2 diabetes and cardiovascular disease. Whole grains products are recommended in New Zealand and abroad in dietary guidelines however current definitions make no mention of fibre structure and particle size, referring only to grain constituents. Given that an increasing number of relatively refined wholegrain products (as presently defined) are now appearing on supermarket shelves, the potential effect of wholegrain particle size must be considered. Wholegrain foods consumed today are very different from those available several decades ago in the prospective studies where the benefit of whole grains were clearly demonstrated, however the health effects of this additional food processing are largely unknown.

We have previously considered the acute (HDEC Ethics 17/STH/41) and short-term (HDEC Ethics 18/STH/172) role of wholegrain structure in blood glucose response. We will now consider the role of wholegrain structural integrity on a long-term marker of blood glucose management of adults with type 2 diabetes (glycated haemoglobin or HbA1c).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116446 0
Dr Andrew Reynolds
Address 116446 0
Department of Medicine
University of Otago
PO Box 56
Dunedin Otago. 9010
Country 116446 0
New Zealand
Phone 116446 0
+64279565826
Fax 116446 0
Email 116446 0
andrew.reynolds@otago.ac.nz
Contact person for public queries
Name 116447 0
Dr Andrew Reynolds
Address 116447 0
Department of Medicine
University of Otago
PO Box 56
Dunedin Otago. 9010
Country 116447 0
New Zealand
Phone 116447 0
+64279565826
Fax 116447 0
Email 116447 0
andrew.reynolds@otago.ac.nz
Contact person for scientific queries
Name 116448 0
Dr Andrew Reynolds
Address 116448 0
Department of Medicine
University of Otago
PO Box 56
Dunedin Otago. 9010
Country 116448 0
New Zealand
Phone 116448 0
+64279565826
Fax 116448 0
Email 116448 0
andrew.reynolds@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not obtained participant consent to share their data beyond the proposed trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14570Study protocol    Please contact the PI Andrew Reynolds andrew.reyno... [More Details]
14571Informed consent form    Please contact the PI Andrew Reynolds andrew.reyno... [More Details]
14572Ethical approval    Please contact the PI Andrew Reynolds andrew.reyno... [More Details]



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.