An investigation into the tolerability of Manuka Cyclopower (trademark)

INTERVENTION: 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. CONDITION: cardio‐vascular risk factors gastro‐intestinal irritation PRIMARY OUTCOME: 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. SECONDARY OUTCOME: To assess for any biochemical changes to inflammatory markers, fasting blood glucose and oral flora 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