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Trial registered on ANZCTR


Registration number
ACTRN12624001305516p
Ethics application status
Submitted, not yet approved
Date submitted
3/10/2024
Date registered
28/10/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Fact or fiction: blood glucose response to ultra-processed foods
Scientific title
Food processing, formulation, and inherent differences in composition on acute blood glucose control in adults with type 2 diabetes: randomised crossover study
Secondary ID [1] 313102 0
None
Universal Trial Number (UTN)
U1111-1310-9438
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 335349 0
Condition category
Condition code
Metabolic and Endocrine 331938 331938 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary interventions: single meal responses to 16 different foods and three glucose standards on 19 different mornings. Each of the foods vary in food type, processing, and formulation, but all contain 25g of available carbohydrate (sugars and starch). The three glucose drink interventions are all the same exposure and also provide 25g of available carbohydrate. The average of the three glucose exposures is used as a way to account for within-person variability in how they respond day-to-day. Foods and glucose drinks are tested inline with the ISO standard for postprandial blood glucose testing. Each intervention is started in the morning with a fasted participant who has 10 minutes to consume the food and three hours sitting in a chair while their capillary blood glucose is measured. Blood glucose measurements are taken from fingers at baseline, then at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. This morning process is conducted under observation. Participants are free to pursue their interests of this three hours, but are required to remain largely sedentary in a chair. The foods being tested are 1) Oranges (225g) either as whole fruit (with and without added fibre, or orange juice (with and without added fibre. 2) Legumes (200g) (cooked plain or with olive oil) or freeze dried cooked legumes (plain or with olive oil). 3) Cow milk (450g, plain or with added protein) or yoghurt made from cow milk (plain or with added protein). 4) Cooked oats (100-170g) either intact (with or without sugar) or milled (with or without sugar). The amount of oats served per morning varies, as the added sugar counts towards the 25g available carbohydrate that determines serve size. Participants will be asked to eat all interventions of that food type (i.e. the oranges), before being asked if they wish to continue to test the next food type (i.e. oats).
Intervention code [1] 329668 0
Lifestyle
Intervention code [2] 329777 0
Treatment: Other
Comparator / control treatment
The primary comparison for each food intervention will be the average of the three glucose drink responses.
Control group
Active

Outcomes
Primary outcome [1] 339542 0
Postprandial blood glucose control
Timepoint [1] 339542 0
The iAUC is measured using the capillary blood glucose measurements taken over the three hours following each dietary intervention at baseline, 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Secondary outcome [1] 440395 0
Hunger
Timepoint [1] 440395 0
Hunger measured at baseline, 30 minutes, 60 minutes, 120 minutes, and 180 minutes following each dietary intervention and glucose drink.
Secondary outcome [2] 440396 0
Satiety
Timepoint [2] 440396 0
Satiety measured at baseline, 30 minutes, 60 minutes, 120 minutes, and 180 minutes following each dietary intervention and glucose drink.

Eligibility
Key inclusion criteria
Participants will be adults 18-75 years diagnosed with type 2 diabetes mellitus. Antihyperglycaemic drug use is permitted, provided a medical professional has not changed dose or type in the last three months. Regular insulin use of the same dose is also permitted, but basal bolus insulin use (changing amount in response to a meal). Presence of comorbidities will not exclude participation.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current pregnancy, lactation, allergies or intolerance to the test foods, and inability or unwillingness to comply with the intervention requirements will exclude participation.

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)
Intervention order by simple randomisation per food type using a computerised sequence generation, no stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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 data. Results will be presented as differences (with 95% confidence intervals) between the interventions and compared with the glucose standard. Analysis will be undertaken in Stata (version 17, StataCorp, TX, USA) with the statistician blinded to the primary analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 26609 0
New Zealand
State/province [1] 26609 0
Otago

Funding & Sponsors
Funding source category [1] 317547 0
University
Name [1] 317547 0
Edgar Diabetes and Obesity Research Centre
Country [1] 317547 0
New Zealand
Funding source category [2] 317549 0
University
Name [2] 317549 0
Riddet Institute, Centre of Research Excellence
Country [2] 317549 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 319855 0
None
Name [1] 319855 0
None
Address [1] 319855 0
Country [1] 319855 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316258 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316258 0
Ethics committee country [1] 316258 0
New Zealand
Date submitted for ethics approval [1] 316258 0
02/10/2024
Approval date [1] 316258 0
Ethics approval number [1] 316258 0

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

Contacts
Principal investigator
Name 137310 0
Dr Andrew Reynolds
Address 137310 0
Department of Medicine, University of Otago, PO Box 56, Dunedin Otago 9010.
Country 137310 0
New Zealand
Phone 137310 0
+64279565826
Fax 137310 0
Email 137310 0
andrew.reynolds@otago.ac.nz
Contact person for public queries
Name 137311 0
Andrew Reynolds
Address 137311 0
Department of Medicine, University of Otago, PO Box 56, Dunedin Otago 9010.
Country 137311 0
New Zealand
Phone 137311 0
+64279565826
Fax 137311 0
Email 137311 0
andrew.reynolds@otago.ac.nz
Contact person for scientific queries
Name 137312 0
Andrew Reynolds
Address 137312 0
Department of Medicine, University of Otago, PO Box 56, Dunedin Otago 9010.
Country 137312 0
New Zealand
Phone 137312 0
+64279565826
Fax 137312 0
Email 137312 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


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.