Effect of Olives on Glycaemic Response in Vivo
Condition: Diabetes
Study type: Interventional

Summary: 
      This research is aimed at determining whether the presence of oleuropein in olives (Olea
      europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will
      be required to consume commercially available olives together with white bread, and their
      glycaemic response will be measured. The blood glucose response of bread will be determined
      initially as a control/reference. Food samples and control will be consumed in random order.

      The recent rise in the cases of Diabetes mellitus in both children and adults has raised a
      concern for the need to proffer immediate solutions amongst scientists in the fields of
      medicine food science and nutrition. One of the approaches of reducing postprandial
      hyperglycaemia and high glucose spikes is to impede digestion and absorption of starch. This
      is potentially achieved through the inhibition of the activities of starch digesting enzymes
      namely alpha amylase and alpha glycosidase. There are currently some antidiabetic drugs such
      as acarbose and miglitol which have been quite efficient in these inhibitory functions but
      not without associated side effects and complications such as liver toxicity, etc, arising
      from to long term usage of such drugs. It therefore becomes imperative for natural
      substitutes from food sources to be explored as better alternatives. At the moment several
      plant foods are under investigation as suitable alternatives, and olives appear to be quite
      promising in this regard. There are quite a few studies that have reported the inhibitory
      activities of olives oleuropein on alpha amylase in vitro but information on in vivo testing
      is very scarce.

      It is expected that the research outcome will be a gateway to the reduction and control of
      the incidence of diabetes mellitus.
    

Detailed description: 
      Prior to commencement of the study, potential volunteers will be given a clear, concise
      Participant Information Sheet and Informed Consent Form by the investigator to read, complete
      and sign in their own time. The investigator will answer all questions to the satisfaction of
      the individual and will not influence the decision of taking part in the study. The
      participants will be free to withdraw from the study at any point without providing a reason.
      The written consent form will be signed and dated at least 2 days prior to enrolment in the
      study by the volunteers and the Investigator. It will be photocopied and one copy will be
      kept by the Investigator (for the study records) and one by the volunteer. Participation by
      the volunteers is conditional upon receiving the written consent by the volunteer.

      Candidates will be asked to complete a questionnaire in order to assess their suitability for
      the study. The information pertains to their lifestyle and may be considered a sensitive
      issue, however each volunteer will be assured of confidentiality and that participation is
      entirely voluntary. The information on the questionnaire will include height, weight, gender,
      age and relevant medical history. Confidentiality of all participants' information will be
      maintained. Identification will be coded using random ID numbers that will be assigned on the
      day of study. All data collected will be treated as confidential and stored securely in a
      locked filing cabinet according to current University regulations. The linkage between
      individual identity and ID number will be kept in written form only and stored in a locked
      filling cabinet in a restricted access area, thus it will not be possible to identify
      individual participants from the ID numbers. Data evaluation will only be performed using ID
      numbers. In accordance with the University guidelines on the password protected M-drive of
      the University server, anonymised data will be stored for at least 5 years.

      Blood glucose will be measured after consumption of test meal/control using a commercially
      available glucometer which is available to be bought by any member of the public and people
      already use them on their own. It measures glucose concentrations immediately and meets the
      accuracy requirement for the ISO 15197 standard. A drop of blood is enough and is obtained
      from participants by means of a mild finger prick using a sterile puncture device designed
      for this purpose for each time point. The finger prick protocol is the WHO/FAO 1998 glycaemic
      index approved protocol. Nine (9) finger pricks will be needed (0, 15, 30, 45, 60, 90, 120,
      150 and 180minutes) will be needed per study session.
    

Intervention name(s): bread without olives; bread with olives
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Olives, oleuropein