A randomized, double-blind, placebo-controlled, cross-over study to evaluate the prebiotic effect of Manuka Honey with Cyclopower (Trademark) capsules in healthy subjects.

The New Zealand Institute for Plant and Food Research0 个研究点目标入组 20 人开始时间: 2015年8月18日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

The New Zealand Institute for Plant and Food Research