Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000624785
Ethics application status
Approved
Date submitted
28/05/2013
Date registered
31/05/2013
Date last updated
5/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a formulated honey in type 2 diabetes
Scientific title
The effects of a formulated honey with cinnamon, chromium and magnesium on glucose tolerance and insulin sensitivity in subjects with type 2 diabetes.
Secondary ID [1] 282581 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 289272 0
Condition category
Condition code
Metabolic and Endocrine 289597 289597 0 0
Diabetes
Alternative and Complementary Medicine 289625 289625 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to compare a formulated honey designed to deliver benefits to people with type 2 diabetes over and above the benefit of honey itself. To this end kanuka honey has been combined with cinnamon, chromium and magnesium to create a honey dietary supplement that may deliver positive effects on blood glucose and insulin levels. 15g of honey orally is administered daily for 40 days containing 200 micrograms chromium, 120mg magnesium and 1.5g cinnamon. Adherence will be monitored by returned amounts of honey at the end of 40days. There will be a 20 day washout period between treatments.
Intervention code [1] 287248 0
Treatment: Other
Comparator / control treatment
Plain kanuka honey will be administered orally, 15g per day for 40 days.
Control group
Active

Outcomes
Primary outcome [1] 289688 0
Fasting glucose by serum assay
Timepoint [1] 289688 0
Baseline, 40 days
Primary outcome [2] 289689 0
Fasting insulin by serum assay
Timepoint [2] 289689 0
Baseline, 40 days
Secondary outcome [1] 303016 0
Blood lipids by serum assay
Timepoint [1] 303016 0
Baseline, 40 days
Secondary outcome [2] 303017 0
HbA1c by serum assay
Timepoint [2] 303017 0
Baseline, 40 days

Eligibility
Key inclusion criteria
Type 2 diabetes on metformin or no oral hypoglycaemic agents
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sulphonylurea or insulin use
Medications that could affect glucose tolerance eg oral steroids
HbA1c level > 80mmol/mol

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)
After the baseline visit the order in which the honeys will be administered will be randomised. Allocation will be done by sealed opaque envelope, sequentially numbered.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence will be computer generated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
masking cannot be used due to the colour and aroma of the cinnamon
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA for area under the curve glucose and insulin from baseline OGTT, then for differences between baseline and 40 days for all variables. A 2 arm crossover trial requires multiples of N=2 as there are 2 possible orders of treatment administration. Previous data on the variability of measurements of glucose tolerance and insulin sensitivity were used to calculate required sample size. Calculations performed using a one-sample T-test and a 2 sided type-1 error rate of 5% revealed a sample size of 12 would be 90% powered to detect a clinically significant difference between the treatment groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
11/12/2013
Date of last participant enrolment
Anticipated
1/06/2014
Actual
11/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 5115 0
New Zealand
State/province [1] 5115 0
Wellington

Funding & Sponsors
Funding source category [1] 287362 0
Commercial sector/Industry
Name [1] 287362 0
Honeylab
Country [1] 287362 0
New Zealand
Primary sponsor type
Individual
Name
Jeremy Krebs
Address
Private Bag 31907
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 286109 0
None
Name [1] 286109 0
Address [1] 286109 0
Country [1] 286109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289338 0
Central Region Health and Disability Ethics Committee
Ethics committee address [1] 289338 0
Ethics committee country [1] 289338 0
New Zealand
Date submitted for ethics approval [1] 289338 0
04/06/2013
Approval date [1] 289338 0
20/08/2013
Ethics approval number [1] 289338 0

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

Contacts
Principal investigator
Name 40374 0
Dr Jeremy Krebs
Address 40374 0
Capital and Coast DHB
Private bag 7902
Wellington 6021
Country 40374 0
New Zealand
Phone 40374 0
+6448062458
Fax 40374 0
Email 40374 0
[email protected]
Contact person for public queries
Name 40375 0
Cecilia Ross
Address 40375 0
Capital and Coast DHB
Private bag 7902
Wellington 6021
Country 40375 0
New Zealand
Phone 40375 0
+6448062458
Fax 40375 0
Email 40375 0
[email protected]
Contact person for scientific queries
Name 40376 0
Amber Parry Strong
Address 40376 0
Capital and Coast DHB
Private bag 7902
Wellington 6021
Country 40376 0
New Zealand
Phone 40376 0
+6448062458
Fax 40376 0
Email 40376 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe effect of a cinnamon-, chromium- and magnesium-formulated honey on glycaemic control, weight loss and lipid parameters in type 2 diabetes: an open-label cross-over randomised controlled trial.2016https://dx.doi.org/10.1007/s00394-015-0926-x
N.B. These documents automatically identified may not have been verified by the study sponsor.