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Trial registered on ANZCTR


Registration number
ACTRN12613001348741
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
10/12/2013
Date last updated
16/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled, parallel group, ascending multiple dose study to evaluate the tolerability of Manuka Honey with Honey CycloPowerTM chewable tablets taken daily by healthy subjects
Scientific title
A randomised, double-blind, placebo-controlled, parallel , ascending multiple dose study to evaluate the tolerability of Manuka Honey with Honey CycloPowerTM chewable tablets taken daily by healthy subjects
Secondary ID [1] 283032 0
nil
Universal Trial Number (UTN)
U1111-1146-9102
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-intestinal effect 289864 0
Oral health and wellness 289865 0
Gastro-intestinal wellness 289866 0
Condition category
Condition code
Alternative and Complementary Medicine 290226 290226 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 291053 291053 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to evaluate safety and tolerability following the oral administration (sucking) of Manuka Honey with Cyclopower a day for 2 weeks. Cohort 1 will take 800mg (1 chewable tablet); Cohort 2 will take 1600mgs (2 tablets); cohort 3 will take 2400mgs (3 chewable tablets); cohort 4 will take 3200mgs (4 tablets); cohort 5 will take 4000mgs (5 tablets) and cohort 6 will take 4,800mg (6 chewable tablets), each cohort takes this amount daily in single or divided doses for 2 weeks (3 tablets 1x3 times daily; 4 tablets 2x2 daily; 5 tablets 2x2 plus 1x1 daily; 6 tablets 2x3 daily) . An exploratory assessment will also be completed to assess the potential benefits on oral health via saliva pH measurement. All unused tablets will be returned.
Intervention code [1] 287752 0
Other interventions
Comparator / control treatment
There is a placebo arm to this trial made up largely of maltodextrin and sorbitol, which will be administered at the same time as the active treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 290247 0
To evaluate the safety and tolerability of a range of doses of Honey Cyclopower chewable tablets in healthy subjects taken orally (sucked) daily for 2 weeks. Mouth swabs will be taken for saliva testing and patients will be required to report any adverse effects including nausea and loose stools.
Timepoint [1] 290247 0
2 weeks
Secondary outcome [1] 304201 0
To evaluate the effect of the study treatment on saliva pH after rinsing the mouth with a 10% sucrose solution
Timepoint [1] 304201 0
2 weeks

Eligibility
Key inclusion criteria
1. 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.
2. Subjects must be non-smoking (no use of tobacco products in the previous 3 months).
3. Subjects must have had no active dental caries within the last 2 years of screening and be willing to avoid intake of food or beverages for at least 1 hour (for the collection of saliva samples) at randomisation and at the final visit.
4. Subjects must have a body mass index (BMI) within the range of 18 to 29 kg/m2 inclusive at screening.
5. Subjects of childbearing potential must be using an acceptable method of contraception for the duration of the study.
6. Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study and understand and sign the written informed consent.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A past medical history of clinically significant disease or abnormality.
2. Known allergy to any bee products or Honey Cyclopower
3. Known allergies or intolerance to fibre-based products
4. Known allergies or intolerance to xylitol or other ingredients in the study treatment
5. 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
6. Use of any recreational drugs in last 7 days prior to initial dosing in this study
7. Significant illness within two (2) weeks prior to initial dosing in this study.
8. Randomisation in a previous study evaluating Manuka Honey with CycloPower within 6 months of initial dosing in this study.
9. 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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The investigator must ensure that all subjects being considered for the study meet the following inclusion and exclusion criteria. Deviation from any entry criterion excludes a subject from enrolment into the study.

Each subject in the study is uniquely identified by a subject number. When the subject has signed the informed consent form, the investigator or his/her staff will assign the subject number for the subject. Informed consent must be obtained before any testing is performed to determine a subject’s eligibility. Any subjects who are screened but do not meet the entry criteria will be allocated a 900 series number. The first screen failure subject will be assigned the number 901, the second 902 etc.
Randomisation and groups selection occurs with the use of a computer software programme and subjects and their specimens are only identifiable by the number that is then allocated to them - identifying data will be held at the head office of Manuka Health NZ Ltd by Dr Mandy Suddes who can then identify the participant should medical treatment be warranted for an adverse event. Dr Suddes will not be involved in any part of the trial that involves contact with participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be generated by computer software programme.
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
Intervention assignment
Parallel
Other design features
randomized, double-blind, placebo-controlled, multiple ascending dose
Phase
Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis
The data will be analysed by Manuka Health New Zealand Ltd. or designee. The decision regarding required participant numbers, sample sizes and consequent statistical analyses are decided by registered statistician Hans Hockey (in conjunction with the Manuka Health team)who works via the University of Waikato.

Recruitment
Recruitment status
Active, not recruiting
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 outside Australia
Country [1] 5316 0
New Zealand
State/province [1] 5316 0

Funding & Sponsors
Funding source category [1] 287802 0
Commercial sector/Industry
Name [1] 287802 0
Manuka Health NZ
Address [1] 287802 0
34 Hannigan Drive
Mt Wellington
Auckland 1072
Country [1] 287802 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Manuka Health NZ
Address
34 Hannigan Drive
Mt Wellington
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 286531 0
Other
Name [1] 286531 0
Waiariki Institute of Technology
Address [1] 286531 0
Mokoioa Drive
Rotorua 3015
Country [1] 286531 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289749 0
Waiariki Ethics Committee
Ethics committee address [1] 289749 0
Mokoia Drive
Rotorua 3015
Ethics committee country [1] 289749 0
New Zealand
Date submitted for ethics approval [1] 289749 0
01/09/2013
Approval date [1] 289749 0
06/09/2013
Ethics approval number [1] 289749 0

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multiple ascending dose study in healthy volunteers. Each subject will participate in one of 4 cohorts. Eligible subjects will receive a total daily dose (either as a single dose, twice daily or three (3) times a day) of Honey Cyclopower chewable tablets at 800mg to 4,800mg total daily dose, or the matching placebo. In each cohort, 8 subjects will receive Honey Cyclopower while 4 will receive matched placebo.

The study will consist of a screening visit (Day -7 to -3), treatment period (Days 1 to 14) after which the final End of Study assessments will be completed. Once randomised, subjects will be given sufficient supplies for 7 days of treatment. After 7 days subjects will then return to the clinic where the subject will be assessed for safety and dosing compliance. Safety assessments will include physical examinations, vital signs, concomitant medications, adverse event and serious adverse event monitoring. If the tolerability is deemed acceptable, a second week of study treatment will be dispensed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42206 0
Dr Lynne Chepulis
Address 42206 0
C/o Waiariki Institute of Technology
Mokoia Drive
Rotorua 3015
Country 42206 0
New Zealand
Phone 42206 0
+64226753353
Fax 42206 0
Email 42206 0
lynne.chepulis@waiariki.ac.nz
Contact person for public queries
Name 42207 0
Ms Evelyn Francis
Address 42207 0
Waikato District Health Board
36 Pearsons Avenue
Claudelands
Hamilton 3214
Country 42207 0
New Zealand
Phone 42207 0
+640213882474
Fax 42207 0
Email 42207 0
gypsy.francis@yahoo.co.nz
Contact person for scientific queries
Name 42208 0
Ms Evelyn Francis
Address 42208 0
Waikato District Health Board
36 Pearsons Avenue
Claudelands
Hamilton 3214
Country 42208 0
New Zealand
Phone 42208 0
+640213882474
Fax 42208 0
Email 42208 0
gypsy.francis@yahoo.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary