HealthyNCT01615588
The Glycaemic Index of Manuka Honey
A study testing Manuka Honey in people with Healthy, run by Waiariki Institute of Technology at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Manuka Honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNew Zealand
- Study dates
- Apr 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy (Body mass index (BMI) 20-25)
- non-smoking
- aged between 18-45 years
- absence of diabetes or chronic illness
- not taking any medications.
Who cannot join
- currently dieting
- suffering from illness or chronic disease
- currently taking medication
- smokers (including recreational)
- outside healthy BMI range
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Manuka Honey
- Keywords
- manuka honey, glycaemic index, blood glucose control, individuals, current disease, medication use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka HoneyDietary supplement
Also called Manuka Health New Zealand Manuka honey
honey was weighed out to provide 25 g of available carbohydrate in 200 ml of water
| Study group | Role | What they receive |
|---|---|---|
| honey | Experimental | Manuka honey Receives: Dietary Supplement: Manuka Honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waiariki Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Manuka Health New Zealand
- Responsible party
- Principal investigator, Dr Lynne Chepulis, Waiariki Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615588
- Sponsor's protocol ID
- Manuka GI Study
- Status last verified
- Jun 2012
- First submitted
- 6 Jun 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Glycaemic Index of Manuka Honey
- ClinicalTrials.gov ID
- NCT01615588
- Acronym / sponsor ID
- Manuka GI Study
- Conditions
- Healthy
- Keywords
- manuka honey, glycaemic index, blood glucose control, individuals, current disease, medication use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Waiariki Institute of TechnologyUniversity, hospital or other
- Collaborators
- Manuka Health New Zealand
- Study start
- Apr 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| honey | Experimental | Dietary Supplement: Manuka HoneyManuka honey |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy (Body mass index (BMI) 20-25)
- non-smoking
- aged between 18-45 years
- absence of diabetes or chronic illness
- not taking any medications.
Key exclusion criteria (5 listed)
- currently dieting
- suffering from illness or chronic disease
- currently taking medication
- smokers (including recreational)
- outside healthy BMI range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuka HoneyAlso: Manuka Health New Zealand Manuka honeyhoney was weighed out to provide 25 g of available carbohydrate in 200 ml of water | Dietary supplement | honey |
Primary outcome
Determine the Glycaemic index of Manuka honey
Time frame: 2 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manuka Honey in people with Healthy, run by Waiariki Institute of Technology at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Glycaemic index of Manuka honey (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.