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Trial registered on ANZCTR
Registration number
ACTRN12613000766718
Ethics application status
Approved
Date submitted
21/01/2013
Date registered
9/07/2013
Date last updated
16/02/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
An investigation into the tolerability of Manuka Cyclopower (trademark)
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Scientific title
An randomised, double blind placebo controlled, parallel ascending multiple dose study to evaluate the tolerability of Honey Cyclopower (trademark) taken daily in healthy volunteers
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Secondary ID [1]
281811
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nil
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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:
gastro-intestinal irritation
288157
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cardio-vascular risk factors
288158
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Condition category
Condition code
Oral and Gastrointestinal
288521
288521
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0
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Normal oral and gastrointestinal development and function
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Blood
288522
288522
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0
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Normal development and function of platelets and erythrocytes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Manuka Honey CycloPower is a near-white fine powder produced by combining (complexing) medical grade (MGO400+) Manuka Honey with alpha cyclodextrin, a naturally occurring sugar molecule. The complexing process uses liquid honey and produces a fine powder which is easily handled and suitable for inclusion into a number of final products and presentations. The product is presented in a hard shell capsule for oral administration.
There are two arms in four cohorts. In the first week one arm of each cohort will recieve a total of 400mg of the product, while all other arms will recieve the higher dosing stated above.
Eligible subjects will receive a total daily dose (either as a single dose or three (3) times a day) of Honey Cyclopower capsules at 400, 800, 1200, 2400, 3600, 4800mg total daily dose, or the matching placebo, taken with food. In each cohort 12 subjects will receive Honey Cyclopower while 4 will receive matching placebo in a completely blinded fashion.
The study will consist of a screening visit (Day -7 to -3), study period (Week 1-4) followed by a post treatment safety follow-up approximately 2 days after final dose. Once randomised, subjects will be given sufficient supplies for 7 days of treatment. At the end of each of the four weeks subjects will then return to the clinic where they will be assessed for safety and dosing compliance.
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Intervention code [1]
286360
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Prevention
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Comparator / control treatment
Placebo made up of maltodextrin, will be given at same dose as active treatment in the equivalent study arm
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To assess the presence of any gastro-irritant or other tolerability issues associated with consumption of Honey Cyclopower. Assessment is made by way of participants reporting any symptoms/effects they are experiencing and physical examination including blood pressure is completed prior to, at the midway point and following testing. It is therefore subjective reported data that will be used for assessment.
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Assessment method [1]
288678
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Timepoint [1]
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End of four week trial period, compared with baseline.
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Secondary outcome [1]
300749
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To assess for any biochemical changes to inflammatory markers, fasting blood glucose and oral flora
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Assessment method [1]
300749
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Timepoint [1]
300749
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End of four week trial period, compared with baseline
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Eligibility
Key inclusion criteria
healthy volunteers
non-smoking
BMI 18-29kg/m2
using contraception if appropriate
able to communicate clearly with research staff and able to give informed consent
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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
medical history of significant disease or abnormality
use of prescription drugs 7 days prior to testing (except for oral contraceptive and analgesia)
use of recreational drugs in the 7 days prior to testing
known allergy or food intolerance to fibre based products
known allergy or intolerance of bee products or Honey Cyclopower
significant illness in the 2 weeks prior to testing
dosing of a study drug within the 30 days prior to testing
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enrolled following signed informed consent. They will then be randomised using computer software and allocated a participant number. This number and the participant initials are the only identifying details on case record forms and will recorded by a party not involved with the research participants.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software will be used to randomise participants
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
ascending multiple dose
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Phase
Phase 2
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Type of endpoint/s
Safety
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Statistical methods / analysis
Study data will be analysed by an independent statistician, who also gave advice determining the participants required to provide statistically relevant results. All calculations regarding trial size, amount of arms required and participant numbers were provided by this statistician.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
9/08/2013
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Actual
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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
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4815
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New Zealand
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State/province [1]
4815
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Rotorua
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Funding & Sponsors
Funding source category [1]
286598
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Commercial sector/Industry
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Name [1]
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Manuka Health NZ Ltd
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Address [1]
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34 Hannigan Drive, Mt Wellington, Auckland 1742
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Country [1]
286598
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New Zealand
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Primary sponsor type
Commercial sector/Industry
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Name
Manuka Health NZ Ltd
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Address
34 Hannigan Drive, Mt Wellington, Auckland 1742
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Country
New Zealand
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Secondary sponsor category [1]
285381
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Other
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Name [1]
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Waiariki Institute of Technology
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Address [1]
285381
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Mokoia Drive, Rotorua 3046
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Country [1]
285381
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288670
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Northern B Health and Disabilty Ethics Committee
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Ethics committee address [1]
288670
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Ministry of Health
PO Box 5013
Wellington
6011
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Ethics committee country [1]
288670
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New Zealand
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Date submitted for ethics approval [1]
288670
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05/02/2013
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Approval date [1]
288670
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Ethics approval number [1]
288670
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Ethics committee name [2]
288671
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Waiariki Institute of Technology Ethics Committee
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Ethics committee address [2]
288671
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Mokoia Drive
Private Bag 3028
Rotorua 3046
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Ethics committee country [2]
288671
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New Zealand
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Date submitted for ethics approval [2]
288671
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01/02/2013
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Approval date [2]
288671
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Ethics approval number [2]
288671
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Summary
Brief summary
Honey Cyclopower is a near white free flowing powder produced by combining medical grade Manuka honey with alpha-cyclodextrin, a naturally occurring cyclical sugar molecule. Manuka honey is well known for its anti-bacterial and anti-inflammatory properties, and evidence exists to suggest it may have a role in lowering blood glucose levels. Alpha-cyclodextrin is a plant based sugar molecule that is sold in the USA as a weight loss support product due to its ability to bind to fat molecules and there is some research to suggest it lowers cholesterol, increases adiponectin and increases insulin sensitivity. While both products have GRAS status there is no researched or agreed limit on consumption of Manuka Cyclopower as it is an entirely new product. Two previous studies investigated the gastro-intestinal effect of Honey Cyclopower, the first using very high single doses and the second using much lower doses in a single day. There appears to be a gastro-irritant element to alpha-cyclodextrin when higher doses are consumed, but tolerable limits are not yet known. This research seeks to investigate two main parameters. The first is the potential effect of titration of the product on gastro-intestinal tolerability of the product and the second to provide an initial assessment of specified biochemical effects linked with the above health related claims.
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Trial website
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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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Dr Lynne Chepulis
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Address
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Waiariki Institute of Technology
School of Nursing and Health Studies
Mokoia Drive, Rotorua 3046
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Country
37206
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New Zealand
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Phone
37206
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+64 022 675 3353
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Fax
37206
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Email
37206
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[email protected]
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Contact person for public queries
Name
37207
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Dr Lynne Chepulis
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Address
37207
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Waiariki Insitute of Technology
School of Nursing and Health Studies
Mokioa Drive, Rotorua 3046
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Country
37207
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New Zealand
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Phone
37207
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+64 022 675 3353
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Fax
37207
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Email
37207
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[email protected]
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Contact person for scientific queries
Name
37208
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Dr Lynne Chepulis
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Address
37208
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Waiariki Insitute of Technology
School of Nursing and Health Studies
Mokioa Drive, Rotorua 3046
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Country
37208
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New Zealand
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Phone
37208
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+64 022 675 3353
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Fax
37208
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Email
37208
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[email protected]
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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
No additional documents have been identified.
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