Acute Effect of Pomegranate Extract on Cognitive Function
Condition: Mental Processes
Study type: Interventional
Phase: Phase 1

Summary: 
      The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a
      two week intervention after a pre-intervention registration and preparation period.

      This study explores whether acute supplementation with pomegranate extract can modulate
      indicators of cognitive function and mood in healthy adults. Changes in physiological and
      biochemical markers are also investigated.
    

Detailed description: 
      Participants are asked to visit the QMU clinical lab three times. The first visit is for
      general information, form completion, measurements and consent plus a practise session on
      COMPASS, the study computer software. Information and consent forms and a screening
      questionnaire are completed. Basic information such as age, sex, weight, height and blood
      pressure data are recorded. Lab visits 2 and 3, which are a week apart, constitute the
      intervention phase.

      Participants are randomly assigned to either the pomegranate extract (PE) or placebo
      group.The researcher and participants are blinded to which capsules they are taking until
      data collection is complete. The randomisation process is carried out by independent
      technical staff who use an internet random number generator site to allocate treatment. The
      PE and placebo capsules look identical and are placed in sealed, labeled, pre-prepared opaque
      containers numbered by technicians.

      At the next lab session (visit 2) participants begin their randomised study arm, taking
      either two pomegranate extract or two placebo capsules with water by mouth. Participants
      repeat the procedure at visit 3, where they crossover to the remaining intervention. Thus if
      participant A consumed placebo capsules at visit 2, the participant would take pomegranate
      extract capsules at visit 3, following a washout period of a week. If participant B consumed
      pomegranate extract on visit 2, the participant would then take the placebo capsules at visit
      3.

      At each visit, participants complete two computer testing sessions lasting approximately 45
      minutes - one pre and one post capsule ingestion. After the capsule is taken there is a one
      hour absorption period before the next computer test session begins.

      Participants are fasted from tea and coffee overnight and abstain for the period of the
      intervention in the morning. On the day before the tests, they are requested to refrain from
      alcohol, recreational drugs, and vigorous exercise.

      Participants are also required to restrict herbal extracts, food supplements and polyphenols
      such as dark chocolate, fruit rich in polyphenols and antioxidants to less than three
      portions for 24 hrs beforehand. A 24 hour pre test food diary is completed to assist in
      compliance. Participants are also advised to have a good night's sleep - at least 6-8 h
      during the night before the study day - and should not be more stressed than usual. These
      aspects are confirmed before participants are allowed to commence their sessions.

      Pre-study saliva collection is completed at home by participants early in the morning. This
      provides a biochemical marker which aims to support both cognitive findings and the results
      from the Bond Lader mood questionnaire completed during the computer testing. Instructions
      are given to participants for saliva collection and the samples analysed for cortisol and
      cortisone. Participants are instructed to have their usual breakfast except for coffee or
      tea. Blood pressure is taken pre and post study on visits 2 and 3.

      The baseline computerised cognitive test battery is administered in the clinic at 9am lasting
      around 45 mins. The investigator then observes the participants consuming their scheduled
      capsules. After a one hour quiet absorption period around 11am, blood pressure is taken
      again. The post cognitive testing battery is completed once more and then a second post study
      saliva collection is taken. Participants complete the intervention around 12 noon. All
      assessments are carried out on a QMU computer, with the same laptop used by each participant
      at baseline and post intervention assessments.

      The cognitive testing is conducted under controlled laboratory conditions with the
      assessments at baseline and post study always performed at the same time of day (between 0830
      and 1200) for each participant.

      Participant responses to the cognitive tests are recorded automatically by the computer
      software during the testing battery at visits 2 and 3.
    

Intervention name(s): Pomegranate Extract; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The first computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, intervention capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.; One computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, placebo capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.
Other intervention name(s): POMANOX
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Pomegranate extract; cognitive function; cognition; polyphenols; memory