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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01615588
Ethics application status
Date submitted
6/06/2012
Date registered
7/06/2012
Date last updated
7/06/2012

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
Other interventions - Manuka Honey

Experimental: honey - Manuka honey


Other interventions: Manuka Honey
honey was weighed out to provide 25 g of available carbohydrate in 200 ml of water

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the Glycaemic index of Manuka honey - 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).
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
Gender
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
Basic Science
Allocation to intervention
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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

No data has been provided for results reporting
Summary results
Other publications