Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000336583
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
26/03/2024
Date last updated
3/08/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of blood glucose excursion after ingestion of konjac rice, cauliflower rice and brown rice in type 1 diabetes.
Scientific title
A comparison of post meal glycaemic excursion after ingestion of konjac glucomannan rice, cauliflower rice and brown rice (control) in type 1 diabetes.
Secondary ID [1] 311566 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 332932 0
Condition category
Condition code
Metabolic and Endocrine 329650 329650 0 0
Diabetes
Diet and Nutrition 329831 329831 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A mixed meal tolerance test of a glucomannan rice to ascertain area under the curve glucose. Participants will attend after a 12 hour fast and consume 1 cup glucomannan (konjac) rice with 25g shredded chicken, 75g steamed frozen mixed vegetables and 10ml soy sauce. The intervention will be administered by a research nurse. Baseline (0 min) satiety will be recorded and the meals will be served subsequently. Participants will rate the palatability of the meal using a 9 point hedonic scale immediately after consumption and satiety questionnaires will be completed at at all timepoints. Participants will be given 15 min to consume the meal. After this they must rest quietly for the remainder of the test. Test meals will be weighed using a digital scale to the nearest 0·2 g. Samples will be taken at timepoints baseline, 30, 60, 90 and 120min for glucose. Wash out between treatments will be 7 days.
Intervention code [1] 328019 0
Treatment: Other
Intervention code [2] 328139 0
Lifestyle
Comparator / control treatment
Brown rice (carbohydrate control) cauliflower rice (no carbohydrate control). Participants will attend after a 12 hour fast and consume 1 cup test rice with 25g shredded chicken, 75g steamed frozen mixed vegetables and 10ml soy sauce. The intervention will be administered by a research nurse. Baseline (0 min) satiety will be recorded and the meals will be served subsequently. Participants will rate the palatability of the meal using a 9 point hedonic scale immediately after consumption and satiety questionnaires will be completed at at all timepoints. Participants will be given 15 min to consume the meal. After this they must rest quietly for the remainder of the test. Test meals will be weighed using a digital scale to the nearest 0·2 g. Samples will be taken at timepoints baseline, 30, 60, 90 and 120min for glucose. Wash out between treatments will be 7 days.
Control group
Active

Outcomes
Primary outcome [1] 337439 0
Area under the curve glucose
Timepoint [1] 337439 0
For each test meal samples will be taken at timepoints baseline, 30, 60, 90 and 120min for glucose. These time points are combined into a single measure as area under the curve. The intervention is taken at baseline, samples at 30, 60, 90 and 120 mins are post meal consumption.
Secondary outcome [1] 431857 0
Satiety
Timepoint [1] 431857 0
Each meal test - satiety is measured at timepoints baseline, 30, 60, 90 and 120min. The intervention is taken at baseline, samples at 30, 60, 90 and 120 mins are post meal consumption.
Secondary outcome [2] 431858 0
Palatability
Timepoint [2] 431858 0
Each meal test palatability is measured immediately after consumption of the test meal at baseline

Eligibility
Key inclusion criteria
Type 1 diabetes for more than one year
Basal bolus insulin regime or insulin pump without the use of automated insulin delivery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant or planning pregnancy
• Breast-feeding
• Elevated HbA1c>85 mmol/mol
• Kidney disease (EGFR<30 or on dialysis)
• History of gastroparesis
• Automatic insulin delivery – closed loop

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/04/2024
Actual
1/05/2024
Date of last participant enrolment
Anticipated
25/11/2024
Actual
Date of last data collection
Anticipated
23/12/2024
Actual
Sample size
Target
15
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 26155 0
New Zealand
State/province [1] 26155 0
Wellington

Funding & Sponsors
Funding source category [1] 315865 0
Charities/Societies/Foundations
Name [1] 315865 0
Maurice and Phyllis Paykel Trust
Country [1] 315865 0
New Zealand
Funding source category [2] 315869 0
Charities/Societies/Foundations
Name [2] 315869 0
Wellington Medical Research Foundation
Country [2] 315869 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora Capital Coast and Hutt Valley
Address
Country
New Zealand
Secondary sponsor category [1] 318008 0
None
Name [1] 318008 0
none
Address [1] 318008 0
Country [1] 318008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314714 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314714 0
Ethics committee country [1] 314714 0
New Zealand
Date submitted for ethics approval [1] 314714 0
21/02/2024
Approval date [1] 314714 0
01/03/2024
Ethics approval number [1] 314714 0
2024 EXP 19351

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

Contacts
Principal investigator
Name 132494 0
Dr Amber Parry Strong
Address 132494 0
Level 5 Grace Neil Block, Wellington Hospital, Wellington 6021
Country 132494 0
New Zealand
Phone 132494 0
+6448062458
Fax 132494 0
Email 132494 0
[email protected]
Contact person for public queries
Name 132495 0
Amber Parry Strong
Address 132495 0
Level 5 Grace Neil Block, Wellington Hospital, Wellington 6021
Country 132495 0
New Zealand
Phone 132495 0
+6448062458
Fax 132495 0
Email 132495 0
[email protected]
Contact person for scientific queries
Name 132496 0
Amber Parry Strong
Address 132496 0
Level 5 Grace Neil Block, Wellington Hospital, Wellington 6021
Country 132496 0
New Zealand
Phone 132496 0
+6448062458
Fax 132496 0
Email 132496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data available on request to protect indigenous data


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.