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

Phase 1

Completed

• Conditions: Gastrointestinal effect and wellness; Alternative and Complementary Medicine - Other alternative and complementary medicine; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12615000857505
• Lead Sponsor: The New Zealand Institute for Plant and Food Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of Manuka honey with Cyclopower for 21 days on faecal bacteria populations in healthy subjects.[At the beginning, during and the end of each treatment period (days 0,1,3, 7,14 and 21 days).]

Secondary Outcome Measures

Name	Time	Method
To investigate gut mediated immune markers resulting from the ingestion of Manuka honey with Cyclopower by faecal IgA analysis. Immune marker is IgA.[At the beginning, before, during and at the end of each treatment (days of 0,1,3,7,14 and 21 days).];To evaluate the safety and tolerability of Manuka honey with Cyclopower by assessing vital signs. [During and at the end of each treatment (days 7,14 and 21 days).];To evaluate the safety and tolerability of Manuka honey with Cyclopower by analyzing blood samples (blood counts and general metabolic health). [At the beginning and the end of each treatment( i.e day 0 and day 21 of each treatment).]