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Trial registered on ANZCTR


Registration number
ACTRN12615000857505
Ethics application status
Approved
Date submitted
8/07/2015
Date registered
18/08/2015
Date last updated
4/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the prebiotic effect of Manuka Honey with Cyclopower (Trademark) capsules in healthy subjects.
Scientific title
A randomized, double-blind, placebo-controlled, cross-over study to evaluate the prebiotic effect of Manuka Honey with Cyclopower (Trademark) capsules in healthy subjects.
Secondary ID [1] 287029 0
Nil
Universal Trial Number (UTN)
U1111-1171-7483
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal effect and wellness 295494 0
Condition category
Condition code
Alternative and Complementary Medicine 295750 295750 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 296129 296129 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manuka Honey with Cyclopower (Trademark) is a fine powder produced by combining (complexing) medical grade (MGO400+) Manuka Honey (45%) with alpha cyclodextrin (55%), a naturally occurring sugar molecule. The complexing process uses liquid honey and produces a fine powder which is presented in a hard shell capsule for oral administration.
The primary objective of this study is to evaluate the prebiotic effect of (total dose of 1600 mg/day) Manuka Honey with CycloPower (Trademark) in healthy volunteers after oral administration for 21 days. Tolerability and safety data will also be reported.
The study will consist of 2 treatment periods (TP1 and TP2) of 3 weeks with an intervening washout period of 2 weeks. After successful screening, eligible subjects will be randomized (Day 0) to receive either the active treatment or matching placebo during TP1. After 2 weeks washout during which they will take no study treatments, subjects will then receive the other treatment during TP2.
Participants will be asked to take two 400 mg Manuka Cyclopower chewable tablets with food, twice per day for 3 weeks. During the course of the study participants will be asked to provide faecal samples at the following time points; on days 0, 1, 3, 7, 14 and 21 of each treatment to evaluate faecal bacterial populations and immune markers. Blood samples will be obtained at the beginning and the end of each treatment to assess general metabolism and blood counts.
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] 292250 0
Treatment: Other
Comparator / control treatment
Placebo made up of glucose, will be given at the same dose as active treatment in the equivalent study arm.
Control group
Placebo

Outcomes
Primary outcome [1] 295481 0
To evaluate the effect of Manuka honey with Cyclopower for 21 days on faecal bacteria populations in healthy subjects.
Timepoint [1] 295481 0
At the beginning, during and the end of each treatment period (days 0,1,3, 7,14 and 21 days).
Secondary outcome [1] 315671 0
To investigate gut mediated immune markers resulting from the ingestion of Manuka honey with Cyclopower by faecal IgA analysis. Immune marker is IgA.
Timepoint [1] 315671 0
At the beginning, before, during and at the end of each treatment (days of 0,1,3,7,14 and 21 days).
Secondary outcome [2] 315733 0
To evaluate the safety and tolerability of Manuka honey with Cyclopower by assessing vital signs.
Timepoint [2] 315733 0
During and at the end of each treatment (days 7,14 and 21 days).
Secondary outcome [3] 316109 0
To evaluate the safety and tolerability of Manuka honey with Cyclopower by analyzing blood samples (blood counts and general metabolic health).
Timepoint [3] 316109 0
At the beginning and the end of each treatment( i.e day 0 and day 21 of each treatment).

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 a body mass index (BMI) within the range of 18 to 29 kg/m2 inclusive at screening.
4. Subjects of childbearing potential must be using an acceptable method of contraception for the duration of the study.
5. 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.
6.Subjects must be willing not to use any other probiotic or prebiotic supplements for the duration of this study. Note: The eating of yoghurt / probiotic foods may continue during the study as long as there is no change in the product eaten or in the amount and frequency of ingestion.
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 food intolerance to fibre-based products
4. 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 hormonal contraceptives
5. Use of any recreational drugs in last 7 days prior to initial dosing in this study
6. Significant illness within two (2) weeks prior to initial dosing.
7. Dosing of a study drug in any clinical investigation within 30 days prior to initial dosing in this study.
8. Pregnant and breast feeding women.

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)
All subjects being considered for the study must 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. 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. Subjects and their specimens are only identifiable by the number that is then allocated to them - identifying data will be held in a locked cabinet at the New Zealand Institute for Plant and Food Research, Palmerston North.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be generated by biometrician using computer software.
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
Crossover
Other design features
randomized, double-blind, placebo-controlled.
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Power calculation for this study was performed on the basis of a previously published study (Gostner et al.,2006 ,British journal of Nutrition, 95, 40-50) to determine the required participant numbers, sample sizes. These researchers found significant differences in relative abundance for three (out of 14) types of bacteria. The power calculations with this data gave the number (20) of participants for 80% power (P=0.05) one tailed.

The data collected during the current study will be analysed by a biometrician at Plant and Food Research, New Zealand.

Recruitment
Recruitment status
Completed
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] 7024 0
New Zealand
State/province [1] 7024 0
Manawatu

Funding & Sponsors
Funding source category [1] 291609 0
Government body
Name [1] 291609 0
New Zealand Institute for Plant and Food Research
Address [1] 291609 0
Plant and Food Research
Private bag 11 600
Palmerston North 4442
Country [1] 291609 0
New Zealand
Funding source category [2] 291610 0
Commercial sector/Industry
Name [2] 291610 0
Manuka Health New Zealand
Address [2] 291610 0
Manuka Health NZ
34 Hannigan Drive
Mt Wellington
Auckland 1072
Country [2] 291610 0
New Zealand
Primary sponsor type
Government body
Name
The New Zealand Institute for Plant and Food Research
Address
Private bag 11600
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 290281 0
Commercial sector/Industry
Name [1] 290281 0
Manuka Health New Zealand
Address [1] 290281 0
34 Hannigan Drive
Mt Wellington
Auckland 1072
Country [1] 290281 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293145 0
New Zealand Health and Disability Ethic Commitee
Ethics committee address [1] 293145 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 293145 0
New Zealand
Date submitted for ethics approval [1] 293145 0
23/07/2015
Approval date [1] 293145 0
26/08/2015
Ethics approval number [1] 293145 0
15/NTA/115

Summary
Brief summary
The primary objective of this study is to evaluate the prebiotic effect of Manuka Honey with CycloPower (Trademark) in healthy volunteers after oral administration for 21 days. Prebiotics are defined as non-digestible substances that pass undigested through the upper part of the gastrointestinal tract and stimulate the growth and/or activity of health promoting bacteria that colonize the large bowel.
The study is a randomized, double-blind, placebo-controlled, cross-over study to evaluate the prebiotic effect of Manuka Honey with CycloPower (Trademark) capsules in healthy subjects. Eligible subjects will consume 1600 mg (2 capsules twice per day) of Manuka Honey with Cyclopower or a matching placebo with food.
The study will consist of 2 treatment periods (TP1 and TP2) of 21 days with an intervening washout period of 14 days.
Following successful screening, eligible subjects will be randomized (Day 0) to receive either the active treatment or matching placebo during TP1. After 2 weeks washout, during which they will take no study treatment, subjects will receive the other treatment during TP2.
Subjects will be given sufficient supplies for 7 days of outpatient treatment after which (Days 7, 14, 21) subjects will return to the clinic for tolerability and dosing compliance assessments. Blood samples will be obtained at the beginning and the end of each treatment to assess general metabolism and blood counts.

Subjects will be provided with containers to collect faecal samples on days 0, 1, 3, 7, 14 and 21 of each treatment which should be returned to the clinic for analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58534 0
Dr Christine Butts
Address 58534 0
New Zealand Institute for Plant and Food Research
Private bag 11 600
Palmerston North 4442
Country 58534 0
New Zealand
Phone 58534 0
+6463556147
Fax 58534 0
+6463517050
Email 58534 0
Chrissie.Butts@plantandfood.co.nz
Contact person for public queries
Name 58535 0
Dr Christine Butts
Address 58535 0
New Zealand Institute for Plant and Food Research
Private bag 11 600
Palmerston North 4442
Country 58535 0
New Zealand
Phone 58535 0
+6463556147
Fax 58535 0
+6463517050
Email 58535 0
Chrissie.Butts@plantandfood.co.nz
Contact person for scientific queries
Name 58536 0
Dr Christine Butts
Address 58536 0
New Zealand Institute for Plant and Food Research
Private bag 11 600
Palmerston North 4442
Country 58536 0
New Zealand
Phone 58536 0
+6463556147
Fax 58536 0
+6463517050
Email 58536 0
Chrissie.Butts@plantandfood.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