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Trial registered on ANZCTR


Registration number
ACTRN12613001349730
Ethics application status
Approved
Date submitted
19/06/2013
Date registered
10/12/2013
Date last updated
16/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Investigation into the Tolerability of Manuka Honey Cyclopower Trademark Chewable Tablets
Scientific title
An Investigation into the Tolerability of Manuka Honey Cyclopower (Trademark) Chewable Tablets in Healthy Volunteers
Secondary ID [1] 282687 0
NIL
Universal Trial Number (UTN)
U1111-1144-5292
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Product tolerability 289400 0
Effects on mouth microflora 289401 0
Condition category
Condition code
Oral and Gastrointestinal 289724 289724 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to take either one or two 800 mg Manuka Cyclopower chewable tablets three times per day for 4 weeks. Dosing is randomised per participant against the allocated participant number and adherence is monitored by investigators who administer the tablets on site on the testing days. Participants are required to return all unused tablets at the end of the study and note and report when they have missed doses either by text, phone call or at the time of tablet return.
Intervention code [1] 287347 0
Other interventions
Comparator / control treatment
PLacebo (maltodextrin) 800 mg (one or two) chewable tablets three times per day
Control group
Placebo

Outcomes
Primary outcome [1] 289820 0
To assess gastrointestinal tolerability of the chewable tablets. Participants are required to report any adverse events, evidently gastro-intestinal or otherwise - each reported adverse effect is assessed by a registered medical practitioner who then decides whether further follow-up is required.
Timepoint [1] 289820 0
Four weeks and at a two week mid-point clinic visit. Participants will also receive a phone call each week from research staff and will be seen at any time they wish contact. The four week period is for participants who experience gastro-intestinal discomfort that is not severe, passes quickly and does not require follow-up (as per registered medical doctor's decision) and who choose to continue with the study.
Secondary outcome [1] 303313 0
To assess the effect of the chewable tablet on oral microflora. This is by way of analysing growth on agar plates taken from oral swabs at a NZ registered testing facility.
Timepoint [1] 303313 0
Four weeks
Secondary outcome [2] 305753 0
The effect on gut micro flora - to be tested using faecal sampling
Timepoint [2] 305753 0
Four weeks

Eligibility
Key inclusion criteria
Healthy subjects age 18 to 45 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs at screening.
Subjects must be non-smoking (no use of tobacco products in the previous 3 months).
Subjects must have a body mass index (BMI) within the range of 18 to 29 kg/m2.
Subjects of childbearing potential must be using an acceptable method of contraception for the duration of the study
Subjects must be willing to omit the following dietary products from their diet during screening and throughout the study: dietary prebiotic fibre/ probiotic dietary products, probiotic yoghurt (such as Yakult, Activate), oral probiotics such as BLIS, laxatives / enhanced dietary fibre products (such as Metamucil)
Subjects must be willing to omit the use of dental hygiene products the morning of saliva sample collection (randomisation and end of study) including brushing the teeth, use of mouth washes, antibacterial gum or lozenges.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A past medical history of clinically significant disease or abnormality including illnesses which affect the gastrointestinal and immune systems
Known allergy to any bee product or Honey Cyclopower
Known allergies or intolerance to fibre-based products
Known allergies or intolerance to xylitol or other ingredients in the study treatment
Have poor oral health as determined by the presence of significant halitosis, active dental cavities or significant gingivitis
Taken any antibiotics in the 3 months prior to screening
Use of any prescription drugs within 7 days prior to initial dosing in this study, other than occasional use of analgesics (less than 3 days in any 7-day period) and/ or hormonal contraceptives
Use of any recreational drugs in last 7 days prior to initial dosing in this study
Significant illness within 2 weeks prior to initial dosing in this study.
Dosing of a study drug in any clinical investigation within 30 days prior to initial dosing in this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are enrolled in the study provided they meet the inclusion criteria, do not meet the exclusion criteria and give informed consent following a meeting with a member of the research team and are fully informed about being involved in this research (e.g. that there may be some gastro-intestinal upset; requirement for attendance at clinics). They are then allocated a participant number and all information gathered from them is only identifiable with that number. The investigator is not aware of what treatment the participant is being given as the product being tested is pre-packaged at a location in a different city, by a separate company, who are solely aware of what is in each package.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer software programme randomises the subjects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analysis will be completed by an independently contracted statistician. This senior level statistician who works via the University of Waikato, also decides, in conjunction with the team of clinical trial specialists employed at Manuka Health NZ the number of participants required for statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2013
Actual
26/08/2013
Date of last participant enrolment
Anticipated
15/10/2013
Actual
23/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 5150 0
New Zealand
State/province [1] 5150 0

Funding & Sponsors
Funding source category [1] 287471 0
Commercial sector/Industry
Name [1] 287471 0
Manuka Health NZ Ltd
Country [1] 287471 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Manuka Health NZ Ltd
Address
34 Hannigan Drive
Saint Johns, AUCKLAND 1072

MAIL: PO Box 87429
Meadowbank
Auckland 1742
Country
New Zealand
Secondary sponsor category [1] 286216 0
None
Name [1] 286216 0
Address [1] 286216 0
Country [1] 286216 0
Other collaborator category [1] 277461 0
Other
Name [1] 277461 0
Waiariki Institute of Technology
Address [1] 277461 0
Mokoia Drive
ROTORUA 3015
Country [1] 277461 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289449 0
Waiariki Institute of Technology Ethics Committee
Ethics committee address [1] 289449 0
Mokoia Drive
ROTORUA 3015
Ethics committee country [1] 289449 0
New Zealand
Date submitted for ethics approval [1] 289449 0
16/08/2013
Approval date [1] 289449 0
16/08/2013
Ethics approval number [1] 289449 0

Summary
Brief summary
The proposed study is a third study to evaluate this product. Participants will this time be asked to consume either 1 or 2 Manuka Cyclopower chewable tablets (800 mg) up to 3 times per day for 4 weeks (maximum intake of 4800 mg). This study will again follow a randomised, placebo-control design and will be run under the supervision of a medical practitioner. Participants will be asked to provide saliva and faecal samples on day 1 and day 28 to allow assessment of changes to oral and gut microflora. These samples will be processed by Plant and Food Research. The study interval for each group has been extended to 4 weeks as this is the period of time required for there to be observable changes in oral flora and it allows for a longer tolerability assessment of the product.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40830 0
Dr Lynne Chepulis
Address 40830 0
c/o Waiariki Institute of Technology
Mokoia Drive
ROTORUA 3015
Country 40830 0
New Zealand
Phone 40830 0
+64 7 346 8754
Fax 40830 0
Email 40830 0
[email protected]
Contact person for public queries
Name 40831 0
Dr Lynne Chepulis
Address 40831 0
c/o Waiariki Institute of Technology
Mokoia Drive
ROTORUA 3015
Country 40831 0
New Zealand
Phone 40831 0
+64 7 346 8754
Fax 40831 0
Email 40831 0
[email protected]
Contact person for scientific queries
Name 40832 0
Dr Lynne Chepulis
Address 40832 0
c/o Waiariki Institute of Technology
Mokoia Drive
ROTORUA 3015
Country 40832 0
New Zealand
Phone 40832 0
+64 7 346 8754
Fax 40832 0
Email 40832 0
[email protected]

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

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Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3945Plain language summaryNo Study completed.

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