An investigation into the tolerability of Manuka Cyclopower (trademark)
An randomised, double blind placebo controlled, parallel ascending multiple dose study to evaluate the tolerability of Honey Cyclopower (trademark) taken daily in healthy volunteers
Manuka Health NZ Ltd
64 participants
Aug 9, 2013
Interventional
Conditions
Summary
Honey Cyclopower is a near white free flowing powder produced by combining medical grade Manuka honey with alpha-cyclodextrin, a naturally occurring cyclical sugar molecule. Manuka honey is well known for its anti-bacterial and anti-inflammatory properties, and evidence exists to suggest it may have a role in lowering blood glucose levels. Alpha-cyclodextrin is a plant based sugar molecule that is sold in the USA as a weight loss support product due to its ability to bind to fat molecules and there is some research to suggest it lowers cholesterol, increases adiponectin and increases insulin sensitivity. While both products have GRAS status there is no researched or agreed limit on consumption of Manuka Cyclopower as it is an entirely new product. Two previous studies investigated the gastro-intestinal effect of Honey Cyclopower, the first using very high single doses and the second using much lower doses in a single day. There appears to be a gastro-irritant element to alpha-cyclodextrin when higher doses are consumed, but tolerable limits are not yet known. This research seeks to investigate two main parameters. The first is the potential effect of titration of the product on gastro-intestinal tolerability of the product and the second to provide an initial assessment of specified biochemical effects linked with the above health related claims.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria7
- medical history of significant disease or abnormality
- use of prescription drugs 7 days prior to testing (except for oral contraceptive and analgesia)
- use of recreational drugs in the 7 days prior to testing
- known allergy or food intolerance to fibre based products
- known allergy or intolerance of bee products or Honey Cyclopower
- significant illness in the 2 weeks prior to testing
- dosing of a study drug within the 30 days prior to testing
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Interventions
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.
Locations(1)
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ACTRN12613000766718