Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000242426
Ethics application status
Approved
Date submitted
11/11/2024
Date registered
3/04/2025
Date last updated
3/04/2025
Date data sharing statement initially provided
3/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a maximally fortified bread on the gut microbiota and management of type 2 diabetes: research trial
Scientific title
Effects of a bread maximally fortified with protein and fibre on cardiometabolic risk factors, metabolites, and gut microbiota in adults with type 2 diabetes: randomised crossover trial
Secondary ID [1] 313352 0
None
Universal Trial Number (UTN)
U1111-1218-0678
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 335709 0
Condition category
Condition code
Metabolic and Endocrine 332276 332276 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the active intervention, a maximally fortified bread high in fibre (14.5g per 100g) and protein (26g per 100g) will be provided to participants, and they will be advised to replace the bread they normally consume with the bread we provide for periods of two weeks. No minimum amount of bread intake will be required from participants. Adherence to this intervention will be monitored for the two weeks of the intervention with a four-day diet record and biomarkers of food intake from plasma sample. This intervention is separated to the other intervention by a washout period of at least two weeks.
Intervention code [1] 329937 0
Lifestyle
Intervention code [2] 329938 0
Treatment: Other
Comparator / control treatment
In the active control group, participants will be provided a non-fortified bread with standard amounts of fibre (3g per 100g) and protein (7g per 100g) with the same instructions to replace the bread they normally consume with the bread we provide. Adherence to this intervention will be monitored for the two weeks of the intervention with a four-day diet record and biomarkers of food intake from plasma sample. This intervention is separated to the other intervention by a washout period of at least two weeks.
Control group
Active

Outcomes
Primary outcome [1] 339844 0
Postprandial glycaemia
Timepoint [1] 339844 0
Daily for three hours after each identifiable meal for the entire two week intervention period.
Primary outcome [2] 339845 0
Breakfast postprandial glycaemia
Timepoint [2] 339845 0
Daily for three hours after each identifiable breakfast for the entire two week intervention period.
Secondary outcome [1] 441624 0
Lunchtime postprandial glycaemia
Timepoint [1] 441624 0
Daily for three hours after each identifiable lunch for the entire two week intervention period.
Secondary outcome [2] 441625 0
Dinner postprandial glycaemia
Timepoint [2] 441625 0
Daily for three hours after each identifiable dinner for the entire two week intervention period.
Secondary outcome [3] 441626 0
Fasting plasma glucose
Timepoint [3] 441626 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [4] 441627 0
Total cholesterol
Timepoint [4] 441627 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [5] 441628 0
LDL cholesterol
Timepoint [5] 441628 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [6] 441629 0
triglycerides
Timepoint [6] 441629 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [7] 441630 0
Body weight (kg)
Timepoint [7] 441630 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [8] 441631 0
Body Mass Index
Timepoint [8] 441631 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [9] 441632 0
Body fat %
Timepoint [9] 441632 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [10] 441633 0
C-reactive protein (CRP)
Timepoint [10] 441633 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [11] 441634 0
blood pressure
Timepoint [11] 441634 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period
Secondary outcome [12] 441635 0
Gut Microbiome
Timepoint [12] 441635 0
Taken prior to commencement of each two week intervention period and immediately following each two week intervention period

Eligibility
Key inclusion criteria
Participants will be aged 18-80 years and have been diagnosed with type 2 diabetes. Participants will have kept their diabetes-related prescribed medication stable for the last three months, and must be willing to comply with the study requirement to consume the provided bread.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current pregnancy or lactation will exclude participation, as well coeliac disease or any health condition that would require participants to avoid bread intake. A change in type or dose of diabetes medication in the past 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)
The computer-generated randomisation list is stored online and unable to be accessed by researchers randomising participants to intervention order. The only researcher able to access and view this list is not involved in participant recruitment or randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation protocol balanced for first-order carryover effects will determine intervention order before the study commencement. No stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Data will be analysed according to intention to treat. A mixed model, which includes a term for order, will be used to analyse the cardiometabolic risk factor data. A more advance ‘omics approach’ that incorporates machine learning will be applied to consider the interactions between microbiome and host due to a higher fibre diet. This omics approach will be conducted in R.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2025
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 26719 0
New Zealand
State/province [1] 26719 0
Otago

Funding & Sponsors
Funding source category [1] 317797 0
University
Name [1] 317797 0
Edgar Diabetes and Obesity Research Centre
Country [1] 317797 0
New Zealand
Funding source category [2] 317798 0
University
Name [2] 317798 0
Riddet Institute, Centre of Research Excellence
Country [2] 317798 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 320125 0
Government body
Name [1] 320125 0
Southern Ter Whatu Ora
Address [1] 320125 0
Country [1] 320125 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316481 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316481 0
Ethics committee country [1] 316481 0
New Zealand
Date submitted for ethics approval [1] 316481 0
11/11/2024
Approval date [1] 316481 0
26/11/2024
Ethics approval number [1] 316481 0

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

Contacts
Principal investigator
Name 138030 0
Dr Andrew Reynolds
Address 138030 0
Department of Medicine, University of Otago, PO Box 56, Dunedin Otago 9010.
Country 138030 0
New Zealand
Phone 138030 0
+61279565826
Fax 138030 0
Email 138030 0
[email protected]
Contact person for public queries
Name 138031 0
Andrew Reynolds
Address 138031 0
Department of Medicine, University of Otago, PO Box 56, Dunedin Otago 9010.
Country 138031 0
New Zealand
Phone 138031 0
+61279565826
Fax 138031 0
Email 138031 0
[email protected]
Contact person for scientific queries
Name 138032 0
Andrew Reynolds
Address 138032 0
Department of Medicine, University of Otago, PO Box 56, Dunedin Otago 9010.
Country 138032 0
New Zealand
Phone 138032 0
+61279565826
Fax 138032 0
Email 138032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is potentially identifiable data - we have not sought permission to share it.



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.