Acute Effects of Mango Leaf Extract (Zynamite®) on Cognitive Function, Mood and Stress
Condition: Cognitive Change; Stress
Study type: Interventional

Summary: 
      This study aims to assess the effects of a single dose of Zynamite® on performance across a
      number of cognitive domains (attention, working memory, episodic memory, executive function),
      as well as during a period of cognitively demanding task performance, and during
      laboratory-induced stress.

      Seventy-two healthy healthy males (50%) and females (50%) aged 18-45 years will be recruited
      from the general population. Participants will be randomised to receive either Zynamite® or
      placebo at testing visit 1, then the treatment they have not already received at testing
      visit 2. A single acute dose will be administered on each of the two testing visits, with at
      least a seven day washout period in between. The study is quantitative; participants will
      complete questionnaires assessing mood, cognitive tasks and an Observed Multitasking Stressor
      (OMS) task (with saliva samples, and blood samples for 50% of the sample). The cognitive/mood
      assessments will take place at baseline, then at 30, 180 and 300 minutes post-dose. The OMS
      assessments will take place at baseline then between 90 and 130 minutes post-dose. For
      participants in the bloods sub-sample, blood samples will be taken at baseline and after the
      300 minute post-dose assessment. Both testing visits will be identical apart from the
      treatment allocated.
    

Detailed description: 
      The proposed study will assess the effects of a single dose of Zynamite® on performance
      across a number of cognitive domains (attention, working memory, episodic memory, executive
      function), as well as during a period of cognitively demanding task performance, and during
      laboratory-induced stress. Zynamite®'s effects will also be assessed in terms of mood, and
      its ability to modulate the physiological and psychological response to an acute stressor.

      The study will follow a randomised, double-blind, placebo-controlled, balanced cross-over
      design, with treatment (Zynamite®, placebo) as a factor. Seventy-two healthy males (50%) and
      females (50%) aged 18-45 years will be recruited using opportunity sampling. Participants
      will be randomised to receive either Zynamite® or placebo at testing visit 1, then the
      treatment they have not already received at testing visit 2. A single acute dose will be
      administered on each of the two testing visits, with at least a seven day washout period in
      between.

      Testing will take place in a suite of testing facilities at the Brain, Performance and
      Nutrition Research Centre with participants visually isolated from each other. Participants
      will attend the laboratory on 3 separate occasions, an introductory visit and two testing
      days (Day 1 and Day 2).

      Visit 1 (screening/training) The Introductory visit to the laboratory will comprise: briefing
      on requirements of the study, obtaining of informed consent, health screening, completion of
      the Caffeine Consumption Questionnaire (CCQ), training on the cognitive and mood measures and
      collection of demographic data.

      Visit 2 Participants will attend the laboratory at a pre-arranged time in the morning having
      consumed a standardised breakfast of cereal and/ or toast at home no later than an hour
      before arrival. They must have refrained from alcohol for 24 hours and caffeine overnight. On
      arrival on each day participants will have a baseline rested measurement taken of their heart
      rate (HR) and galvanic skin response (GSR) taken, will complete the Profile of Mood States
      (POMS)(Mood/depression/arousal) followed by a 60 minute computerised cognitive assessment
      (COMPASS - including the Cognitive Demand Battery). This will be followed by completion of
      the Observed Multitasking Stressor (OMS) test session. This 5-10 minute OMS takes place under
      observation (which will include being observed by a panel and video and voice recordings)
      comprises provision of a saliva sample, completion of the State Trait Anxiety Inventory
      (STAI)-state, and visual analogue scales (VAS) which are completed before and after the
      stressor. The stressor comprises the performance of a verbal Serial 7s subtraction task
      whilst concomitantly performing a computerised tracking task. Finally a further saliva sample
      is taken. HR and GSR are recorded throughout. After the first cognitive/OMS assessment
      participants will take their treatment for the day and will undergo cognitive/mood
      assessments identical to the above at 30 minutes, 180 minutes and 300 minutes post-dose. The
      post-dose OMS assessment will take place between 90 and 130 minutes post-dose.

      Blood samples will be taken from 50% of the participants both before the pre-dose, baseline
      assessment and after the 300 minute post-dose assessment. The two testing days (Day 1/Day2)
      will be identical, with the exception that participants will take a different treatment on
      each day.

      Visit 3 (at least 7 days later) The methodology during this visit will be identical to visit
      2, with the exception that participants will consume a different treatment during this visit.
    

Intervention name(s): Zynamite®; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Zynamite® is a novel mango (Mangifera indica) leaf extract standardized to contain 60% of the polyphenol mangiferin. Zynamite® is classified as a food or food supplement and is available for purchase within the EU. Zynamite® is not associated with any significant deleterious side effects.; Placebo comparator (carrier)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Balanced crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: cognition; cognitive performance; stress; nutrition; memory; attention; mental performance; mood