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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)
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
Secondary ID [1] 281811 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastro-intestinal irritation 288157 0
cardio-vascular risk factors 288158 0
Condition category
Condition code
Oral and Gastrointestinal 288521 288521 0 0
Normal oral and gastrointestinal development and function
Blood 288522 288522 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286360 0
Prevention
Comparator / control treatment
Placebo made up of maltodextrin, will be given at same dose as active treatment in the equivalent study arm
Control group
Placebo

Outcomes
Primary outcome [1] 288678 0
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.
Timepoint [1] 288678 0
End of four week trial period, compared with baseline.
Secondary outcome [1] 300749 0
To assess for any biochemical changes to inflammatory markers, fasting blood glucose and oral flora
Timepoint [1] 300749 0
End of four week trial period, compared with baseline

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software will be used to randomise participants
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
ascending multiple dose
Phase
Phase 2
Type of endpoint/s
Safety
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 4815 0
New Zealand
State/province [1] 4815 0
Rotorua

Funding & Sponsors
Funding source category [1] 286598 0
Commercial sector/Industry
Name [1] 286598 0
Manuka Health NZ Ltd
Country [1] 286598 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Manuka Health NZ Ltd
Address
34 Hannigan Drive, Mt Wellington, Auckland 1742
Country
New Zealand
Secondary sponsor category [1] 285381 0
Other
Name [1] 285381 0
Waiariki Institute of Technology
Address [1] 285381 0
Mokoia Drive, Rotorua 3046
Country [1] 285381 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288670 0
Northern B Health and Disabilty Ethics Committee
Ethics committee address [1] 288670 0
Ethics committee country [1] 288670 0
New Zealand
Date submitted for ethics approval [1] 288670 0
05/02/2013
Approval date [1] 288670 0
Ethics approval number [1] 288670 0
Ethics committee name [2] 288671 0
Waiariki Institute of Technology Ethics Committee
Ethics committee address [2] 288671 0
Ethics committee country [2] 288671 0
New Zealand
Date submitted for ethics approval [2] 288671 0
01/02/2013
Approval date [2] 288671 0
Ethics approval number [2] 288671 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37206 0
Dr Lynne Chepulis
Address 37206 0
Waiariki Institute of Technology
School of Nursing and Health Studies
Mokoia Drive, Rotorua 3046
Country 37206 0
New Zealand
Phone 37206 0
+64 022 675 3353
Fax 37206 0
Email 37206 0
lynne.chepulis@waiariki.ac.nz
Contact person for public queries
Name 37207 0
Lynne Chepulis
Address 37207 0
Waiariki Insitute of Technology
School of Nursing and Health Studies
Mokioa Drive, Rotorua 3046
Country 37207 0
New Zealand
Phone 37207 0
+64 022 675 3353
Fax 37207 0
Email 37207 0
lynne.chepulis@waiariki.ac.nz
Contact person for scientific queries
Name 37208 0
Lynne Chepulis
Address 37208 0
Waiariki Insitute of Technology
School of Nursing and Health Studies
Mokioa Drive, Rotorua 3046
Country 37208 0
New Zealand
Phone 37208 0
+64 022 675 3353
Fax 37208 0
Email 37208 0
lynne.chepulis@waiariki.ac.nz

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.