None listed
Conditions
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.
Interventions
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.
Sponsors
Manuka Health NZ Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed