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Trial registered on ANZCTR


Registration number
ACTRN12620000095965
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
4/02/2020
Date last updated
31/05/2022
Date data sharing statement initially provided
4/02/2020
Date results provided
31/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate safety and optimal dose of Dahlia Extract in people with pre-diabetes or type 2 diabetes.
Scientific title
A 4-week, placebo-controlled, dose-ramping study to investigate the safety and optimal dose of Dahlia Extract in people with either pre-diabetes or type 2 diabetes.
Secondary ID [1] 300108 0
None
Universal Trial Number (UTN)
U1111-1244-5754
Trial acronym
None
Linked study record
ACTRN12617001605381 is a parent study of this study

Health condition
Health condition(s) or problem(s) studied:
Pre Diabetes 315638 0
type 2 Diabetes 315639 0
Condition category
Condition code
Metabolic and Endocrine 313932 313932 0 0
Diabetes
Alternative and Complementary Medicine 314173 314173 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Dahlia spp. extract, the subject of previous study described in application ACTRN12617001605381. THis is an oral capsule. This study is a placebo controlled dose-ramping study randomised for dose frequency and time of administration. Participants will be randomised into four equal groups stratified by metformin use and by HbA1c. Each group will then complete a dose-ramping protocol over four weeks as outlined in the protocol. Two groups will receive the extract three times per day and two groups twice per day. For both conditions, one group with take it immediately prior to a meal and the other one hour prior to meals. In week one all participants will receive placebo. In week two the extract dose will be 30mg (BD or TDS as above). week three, 60mg and week four 120mg. Adherence will be monitored with capsule return and count using blister packing for each week. Participants will have a subcutaneous continuous glucose monitor for all four weeks of the study.
Intervention code [1] 316386 0
Treatment: Other
Comparator / control treatment
The placebo is a microcrystalline Cellulose capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 322324 0
Glucose data from the Libre will be analysed to determine area under the curve for glucose over 24 hours, and divided into 3-5 hour postprandial periods for each meal. Data will be extracted and averaged for days 4-7 of each treatment dose to allow for steady state to be reached.
Timepoint [1] 322324 0
Each timepoint (week 2, 3 and 4) will be analysed relative to the baseline week (week 1). Baseline AUC glucose will be taken as the average of days 4-7 of the first week while participants receiving placebo.
Secondary outcome [1] 378085 0
A secondary analysis will also be conducted to compare BD vs TDS dosing for AUC over 24 hours. An analysis will also be conducted to compare timing of doses before meals, for AUC over the 5-hour post prandial period following meals where a dose has been given.
Timepoint [1] 378085 0
Secondary analyses will compare conditions between groups at the same timepoint for each dose. Ie the average of days 4-7 AUC glucose during each dosage regimen.

Eligibility
Key inclusion criteria
Males 18 years and over
Pre-diabetes or type 2 diabetes with HbA1c between 45 mmol/mol and 60 mmol/mol
Willing to maintain a stable lifestyle throughout the study
Minimum age
18 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Using any diabetes drug other than Metformin
• Previous bariatric surgery
• Pregnancy or breast feeding
• Liver disease or AST/ ALT >3x ULN
• Diabetic nephropathy with an eGFR <60.
• Stage 3 or 4 NYHF heart failure
• Proliferative retinopathy
• Allergy to sports tape
• Any other long-term condition considered inappropriate by principal investigator.

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)
Participants will be computer randomised into 4 treatment groups with allocation made on sequential basis by staff member not directly involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistician who is not involved directly with the study will provide a randomisation list, stratified by metformin use. Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed by treatment group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2020
Actual
4/03/2020
Date of last participant enrolment
Anticipated
30/07/2021
Actual
13/07/2021
Date of last data collection
Anticipated
31/08/2021
Actual
10/08/2021
Sample size
Target
40
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 22188 0
New Zealand
State/province [1] 22188 0
Wellington

Funding & Sponsors
Funding source category [1] 304552 0
Commercial sector/Industry
Name [1] 304552 0
Aroma NZ
Country [1] 304552 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Aroma NZ
Address
12 Senior Place
Christchurch 8062
New Zealand
Country
New Zealand
Secondary sponsor category [1] 304836 0
None
Name [1] 304836 0
None
Address [1] 304836 0
none
Country [1] 304836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304979 0
NZ Health and Disability Ethics Committee - Central
Ethics committee address [1] 304979 0
Ethics committee country [1] 304979 0
New Zealand
Date submitted for ethics approval [1] 304979 0
28/11/2019
Approval date [1] 304979 0
19/12/2019
Ethics approval number [1] 304979 0
19/CEN/206

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

Contacts
Principal investigator
Name 98842 0
Prof Jeremy Krebs
Address 98842 0
Wellington Hospital Riddiford St Wellington 6021
Country 98842 0
New Zealand
Phone 98842 0
+6448062458
Fax 98842 0
Email 98842 0
[email protected]
Contact person for public queries
Name 98843 0
Amber Parry Strong
Address 98843 0
Wellington Hospital Riddiford St Wellington 6021
Country 98843 0
New Zealand
Phone 98843 0
+6448062458
Fax 98843 0
Email 98843 0
[email protected]
Contact person for scientific queries
Name 98844 0
Jeremy Krebs
Address 98844 0
Wellington Hospital Riddiford St Wellington 6021
Country 98844 0
New Zealand
Phone 98844 0
+6448062458
Fax 98844 0
Email 98844 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
This data is commercially sensitive.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6203Study protocol    378946-(Uploaded-17-12-2019-11-08-07)-Study-related document.docx



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.