An Investigation Into the Effects of Blueberry Anthocyanin on Cognitive Functioning and Mood in Adolescents.
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a 4-week dietary intervention with wild
      blueberry powder can have an effect on cognitive performance in participants aged between
      13-17.
    

Detailed description: 
      Interventions: Flavonoid drink and a matched placebo will be used in this study. Flavonoid
      drink will contain approximately, 13g of freeze dried wild blueberry powder, containing 250mg
      of anthocyanin flavonoid, mixed with 170ml water and flavored with 30ml 'Rock's Organic
      Orange Squash' as it has a low flavonoid content. The placebo drink will contain placebo
      powder matched for vitamin C (45mg), glucose (4.52g) and fructose (4.79g), mixed with 170ml
      of water and 30ml 'Rock's Organic Orange Squash'. Participants will be randomly allocated to
      either placebo or treatment. Participants will be instructed to consume the drink every
      morning for 4 weeks. The powder will be prepared and sealed in opaque packets. Participants
      will be provided with 2 weeks worth of supplies at baseline and then in week 2. Parents will
      be provided with instructions on how to prepare the drinks in addition to supplies such as
      opaque straws and containers. Assessment of left-over product will be conducted in 2 weeks to
      allow for continued compliance verification.

      Procedure: the study comprises of a screen and four visits, including a familiarization week
      and 2 test visits.

        1. Screening: Once a school has indicated interest in aiding with this trial, participants
           will be given a brief overview of the study and asked to complete a set of
           questionnaires regarding their mood and general health to confirm suitability for
           participating in this study. The questionnaires include Mood and Feeling Questionnaire
           (MFQ) and Revised Child Anxiety and Depression Scale (RCADS).Participants who score 27
           or above (depressed) and score 14 or below (healthy) on the MFQ will be invited to
           participate in the second part of the study. Parents of the participants meeting the
           criteria will then be contacted to ascertain that each interested volunteer and parents
           are willing to participate for the entire duration of the study and to schedule their
           familiarization visit.

        2. Familiarization Visit: Volunteers and parents will be invited to volunteers' first visit
           at the location of volunteers' choice (Nutritional Psychology Unit at the University of
           Reading or volunteers' school) where participants will receive a detailed explanation of
           the study by the participating research associate and will be asked to sign the informed
           consent form before any study procedure starts. A log will be kept identifying all
           participants having signed the informed consent form (ICF) and the participant will be
           allocated a participant number. Once consent has been given, the participants will then
           be asked to complete the EPIC Food Frequency Questionnaire so that background flavonoid
           intakes can be measured prior to the start of the intervention, Rumination Response
           Scale (RRS) and a General health questionnaire. Participants intelligence quotient (IQ)
           will be assessed using The Wechsler Abbreviated Scale of Intelligence (WASIII). Parents
           will also be asked to complete questionnaires, regarding children mood and behaviors,
           including the Parent version of MFQ, RCADS and attention deficit hyperactivity disorder
           (ADHD) Rating Scale-IV. Finally, participants will be given training on the cognitive
           test battery (tasks outlined below) that will be used during the study to reduce the
           chances of 'practice' adversely affecting performance on subsequent test days.

        3. Test Visits (Weeks 0, 2 and 4): All of these sessions will be held at times that suit
           participants' individual needs. The timings of the testing sessions will be consistent
           for each participant over the 4 weeks. Upon arrival, participants will be asked of any
           adverse events and any issues with compliance. Participants will then complete the
           battery of cognitive tasks consisting of (i) Modified Eriksen Flanker task, (ii) The
           Keep track task (KTT) and (iii)The Controlled Oral Word Association Test (COWAT), in
           addition to completing the daily mood measure Positive and Negative Affect Schedule
           (PANAS). Additionally, the last test session (week 4) participants and parents' will
           once again be asked to complete the MFQ, RCADS and RRS mentioned above.

      Participants may stop the study treatment without stating any reason at any time during the
      study. In addition, a participant will be withdrawn from the study if a volunteer or parents
      request a discontinuation, participant exhibits a serious adverse event to any component of
      the test product, an illness emerges and/or the investigator's opinion is that withdrawal is
      appropriate and in the best interest of the participant. If a participant withdraws from the
      study, participants will be encouraged to make a final visit as soon as possible,
      irrespective of the reason for withdrawal, to complete a final battery of cognitive tasks.
    

Intervention name(s): Wild Blueberry Powder-13g; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C; Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants will be assigned to either a Placebo or Blueberry (treatment) drink, in parallel for the duration of the study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: low mood, depression