Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01615588




Registration number
NCT01615588
Ethics application status
Date submitted
6/06/2012
Date registered
8/06/2012
Date last updated
8/06/2012

Titles & IDs
Public title
The Glycaemic Index of Manuka Honey
Scientific title
The Glycaemic Index of Manuka Honey
Secondary ID [1] 0 0
Manuka GI Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Manuka Honey

Experimental: honey - Manuka honey


Treatment: Other: Manuka Honey
honey was weighed out to provide 25 g of available carbohydrate in 200 ml of water
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the Glycaemic index of Manuka honey
Timepoint [1] 0 0
2 weeks

Eligibility
Key inclusion criteria
* healthy (Body mass index (BMI) 20-25)
* non-smoking
* aged between 18-45 years
* absence of diabetes or chronic illness
* not taking any medications.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* currently dieting
* suffering from illness or chronic disease
* currently taking medication
* smokers (including recreational)
* outside healthy BMI range

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
BOP

Funding & Sponsors
Primary sponsor type
Other
Name
Waiariki Institute of Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Manuka Health New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different geographical locales around the North Island of New Zealand and tested for glycaemic index (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed honey containing 25g of available carbohydrate in 200 ml water and the blood glucose responses measured (area under the curve; AUC) and compared to that of 25 g of available carbohydrate from glucose.
Trial website
https://clinicaltrials.gov/study/NCT01615588
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01615588