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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
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Scientific title
The Glycaemic Index of Manuka Honey
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Secondary ID [1]
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Manuka GI Study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Determine the Glycaemic index of Manuka honey
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Assessment method [1]
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10 healthy individuals consumed honey (25g of available carbohydrate in 200 ml of water) in a fasted state. Blood glucose levels were recorded at 0, 15, 30, 45, 60, 90 and 120 mins and the area under the blood glucose curve was calculated. All 10 participants took five different honeys and a glucose standard on six different days (with randomised allocation of samples).
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Timepoint [1]
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2 weeks
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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.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* currently dieting
* suffering from illness or chronic disease
* currently taking medication
* smokers (including recreational)
* outside healthy BMI range
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2012
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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BOP
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Funding & Sponsors
Primary sponsor type
Other
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Name
Waiariki Institute of Technology
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Manuka Health New Zealand
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01615588
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01615588
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