A study to evaluate the prebiotic effect of Manuka Honey with Cyclopower (Trademark) capsules in healthy subjects.

INTERVENTION: 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. CONDITION: Gastrointestinal effect and wellness PRIMARY OUTCOME: To evaluate the effect of Manuka honey with Cyclopower for 21 days on faecal bacteria populations in healthy subjects. SECONDARY OUTCOME: To evaluate the safety and tolerability of Manuka honey with Cyclopower by analyzing blood samples (blood counts and general metabolic health). To evaluate the safety and tolerability of Manuka honey with Cyclopower by assessing vital signs. To investigate gut mediated immune markers resulting from the ingestion of Manuka honey with Cyclopower by faecal IgA analysis. Immune marker is IgA. 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.