Investigation of the Acute and Chronic Cognitive and Mood Effects of CP9700 in Humans
Condition: Cognitive Function; Mood
Study type: Interventional

Summary: 
      This acute-on-chronic study will examine the effectiveness of CP9700 for improving cognitive
      performance and mood in healthy young adults. CP9700 is a mix of highly purified grape
      seed-derived polyphenolic extracts from Vitis vinifera produced by Polyphenolics Inc.
      (Madera, CA, USA). The polyphenolic component of the product is comprised entirely of
      catechin and epicatechin, derivatives of catechin and epicatechin (e.g.,epicatechin gallate),
      and proanthocyanidins. We will perform a randomised, double-blind, parallel-groups human
      intervention trial using CP9700 and a well characterised sugar-matched placebo to investigate
      changes in cognitive performance.
    

Detailed description: 
      Interventions: Two interventions will be tested, CP9700 (400 mg) and a placebo. Importantly,
      the placebo will be matched to the active treatment for sugars and vitamin C levels. All
      interventions will be supplied in blister packs.

      Participants: A total of 60 healthy, young adult participants will be recruited for these
      studies. Based upon the medium effect size (d = .65) observed in previous work using healthy
      adults and the Go/No go task, we calculate that a sample of 25 participants/treatment will
      provide considerable power (.70) to detect a similar sized effect in this study. The
      recruitment procedure allows for a 15% drop out rate. Participants will be recruited directly
      from the School of Psychology & Clinical Language Sciences Undergraduate Research Panel.

      Procedure: Following recruitment to the study, participants will start a two-week 'run-in'
      phase. During this phase, all participants will complete a 3-day food frequency questionnaire
      to give a measure of their habitual diet before being asked to adhere to a low-flavonoid
      diet, we will collect a 3-day food diary to check compliance and they will attend the
      laboratory for an initial 'practice' session of the cognitive tasks (see below). On the
      evening before the 'active treatment' phase commences, participants will be asked to consume
      a standard meal- this procedure will be repeated for each evening meal consumed prior to a
      test day. On the acute test day, participants will attend the laboratory in a fasted state
      where they will receive a standard low-flavanoid breakfast, followed by a battery of
      cognitive and mood tasks (see below). Subjects will then be given their intervention, and
      will be re-tested on our task battery at two-hourly intervals over a 6 hour period before
      being allowed to return home. During the chronic phase of the study, after 6 and 12 weeks of
      consuming the intervention, subjects will return to the lab in a fasted state (prior to
      taking their daily intervention), will be given a standard low flavonoid breakfast, and will
      be tested on the task battery before consuming their allocated intervention. Compliance will
      be assured through collection of used blister packs.

      The task battery is composed of cognitive tests and measures of mood, which our previous data
      show to be sensitive to flavonoid interventions, both acutely and chronically. More
      generally, the cognitive tests are categorised into one of two key cognitive domains; (i)
      Executive Function (i.e., Serial Sevens, Stroop, Modified Attention Network Test) and (ii)
      Episodic Memory (i.e., immediate and delayed auditory recall, verbal recognition, immediate
      and delayed spatial memory). Moreover, our previous data indicates increased cerebral blood
      flow in the in the acute postprandial phase 2-5 hours following flavonoid consumption in
      brain regions required for executive function and episodic memory including the frontal
      cortex and frontal gyrus. In addition, changes in mood will be measured using the PANAS,
      which has previously been shown to be sensitive to flavonoid interventions acutely and
      chronically.
    

Intervention name(s): CP9700; Matched Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg CP9700 along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen.; Maltodextrin along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Acute on chronic
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cognition; Mood; Flavonoid; Grape Seed; Catechin; Epicatechin; Proanthocyanidin