Acute and Chronic Effects of 100% Florida Orange Juice Consumption on Cognitive Performance in 7-10 Year Old Children
Condition: Healthy
Study type: Interventional

Summary: 
      This study is a 10-week intervention study to examine the acute and chronic effects of daily
      intake of a 100 % orange juice drink vs control drink on cognitive performance. The study
      aims to determine if there are any benefits of whole orange juice intake on cognitive
      performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an
      improvement in performance at week 10).
    

Detailed description: 
      This study will employ a randomised 10 week, parallel groups, double blind, placebo
      controlled design to investigate the effects of daily supplemental orange juice compared with
      an equicaloric placebo orange drink on cognitive performance in 7-10 year old school
      children. Following screening, participants will be randomly assigned to one of two
      conditions: (1) Active group: 100% orange juice, (2) Placebo group: control drink (containing
      equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour). Both
      the active and control groups will receive a drink daily for 10 weeks delivered as a
      school-based morning intervention administered by researchers. Children will also be given
      drinks to consume over the weekends and school holidays monitored by a drink intake diary.
      Participants, parents and teachers will be blind to their assigned condition. Researchers
      will also be blinded until completion of the data analysis.

      Following a practise session at screening (week -1) to familiarise the participants with the
      cognitive tests and study drinks, participants will take part in 3 test sessions - at
      baseline (Week 0), on Day 1 of intervention (start of Week 1; acute effects) and immediately
      post intervention (end of Week 10; chronic effects).

      At week -1 (screening) children will be tested for colour blindness (Ishihara test) and
      complete the Wechsler abbreviated scale of intelligence (WASI) for screening purposes.
      Respiratory peak flow, height, and weight will also be measured to examine the relationship
      between cognitive performance and physical activity.

      This study design, including both the test day and morning juice supplementation, is intended
      to emulate the children's normal routine as far as possible. Each carton of juice will be
      provided mid-morning to act as a supplement to their usual diet.

      Measures:

      The cognitive tests included in the study are listed below:

        -  Immediate and delayed picture recognition

        -  Delayed spatial memory

        -  Tower of Hanoi (executive function - planning/strategy)

        -  Corsi block tapping test (executive function and working memory)
    

Intervention name(s): 100% Florida OJ; Placebo Equicaloric Orange Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Orange Juice, Polyphenol, Cognition