Investigating the Acute and Chronic Effects of an American Ginseng Root Extract on Cognition and Mood
Condition: Cognitive Change; Effects of Ginseng on Cognitive Function
Study type: Interventional

Summary: 
      Ginseng refers to the extract of any slow growing perennial plant with a fleshy root,
      deriving from the Panax genus of the Araliaceae family. Ginseng root has been used as an
      intervention for the treatment of diabetes (Sotaniemi, Haapakoski & Rautio, 1995), boosting
      cognitive function (Scholey et al., 2010) and improving mental health (Ellis & Reddy, 2002).
      The most commonly used ginseng is Panax ginseng (Asia) and Panax quinquefolius (America).
      Ginsensosides are considered the core phytochemical compounds that contribute to the alleged
      beneficial effects of ginseng. In particular, ginsenosides Rb1 and Rg1 have been isolated and
      investigated for effects on cognitive function (Shin et al., 2016).

      Scholey et al. (2010) was one of the first studies to provide support for a beneficial
      cognitive effect from American ginseng (Cereboost™), with better performance on working
      memory in healthy young adults. Improvements were most profound for a single dose of 200 mg
      on working memory tasks, specifically immediate word recall and numeric working memory speed.
      Cereboost also increased self-rated calmness compared to placebo, suggesting ginseng can
      enhance aspects of mood. Similarly, Ossoukhova et al. (2015) compared a single 200mg dose to
      placebo to investigate whether beneficial cognitive effects extend to a middle-aged cohort.
      Here, Cereboost significantly improved performance on the Cognitive Drug Research (CDR)
      working memory factor, specifically improving spatial working memory at three hours post
      dose.

      Further study is required to evaluate ginseng specific effects with a standardized extract of
      P. quinquefolius, such as Cereboost™ on healthy participants. Significant results will have
      implications for investigating the neurocognitive effects in other populations, such as those
      with cognitive and memory problems.
    

Detailed description: 
      The study comprises of a familiarisation visit and then two test days. The test days are
      separated by a 2 week interval during which time participants will be asked to consume a
      daily capsule for 14 days which will contain either an American ginseng root extract (200 mg
      Cereboost and Maltodextrin) or an identical placebo that does not contain any of the active
      ingredient. Participants will be asked to restrict their intake of certain foods for 48 hours
      before test days and intake of alcohol and caffeinated drinks for 24 hours prior. All
      participants will be required to fast overnight prior to each of the study days. Participants
      may withdraw at any time without giving any reason. In addition, a participant will be
      withdrawn from the study if they request discontinuation, exhibit a serious adverse event to
      any component of the test product, the participant significantly violates the exclusion or
      inclusion criteria, an illness emerges and/or opinion is that withdrawal is appropriate.

      An outline of each session is as follows:

        1. Familiarisation/practice visit: Volunteers will attend the Nutritional Psychology unit
           at the University of Reading, where they will receive a detailed explanation on the
           study and will be asked to sign the informed consent form. Once consent has been given
           the inclusion/exclusion criteria will be checked and measures of age, height and weight
           will be taken. Participants will then be asked to fill out a food frequency
           questionnaire before completing training on the cognitive test battery. Participants
           will be given two food diaries, with each diary completed in the 48 hours before each
           test day to check habitual diet and ensure they followed low flavonoid protocol. Finally
           the PANAS - X will be administered to gain a measure of trait mood

        2. Test visits: On arrival of their first test day, participants will be randomly assigned
           to treatment (200 mg Cereboost™) or placebo condition. Each study day will begin at 9am
           with breakfast before completion of the computerized test battery to establish baseline
           performance. Participants will then take their allocated intervention and will be tested
           on the cognitive and mood battery at 2, 4 and 6 hours after consumption. A standard
           light lunch will be provided between the 2hr and 4 hr test points. On test visit 2,
           participants will have completed a 14 day course of their intervention and will be
           tested at the same time points at test visit 1, again receiving the intervention
           directly after the baseline test battery. Finally the PANAS - X will be administered
           again to gain a measure of trait mood following the 2 week intervention.

      The computerized cognitive battery will include tests which are known to be sensitive to
      nutritional manipulations (Lamport, 2012) and will last no more than 45 minutes.
    

Intervention name(s): Cereboost; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200mg Cereboost and Maltodextrin capsules; 200mg Maltodextrin capsules
Other intervention name(s): American ginseng
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between and within groups model
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment