Different Types of Fruits on Metabolic Function and Cognitive Performance
Condition: Healthy
Study type: Interventional

Summary: 
      Primary objective is to assess the effect of the intake of different types of fruits on
      memory and attention.

      Secondary objective is to assess effect of intake of different types of fruits on metabolic
      markers, including glucose, insulin, total cholesterol and triglyceride and the
      pharmacokinetic profile of the anthocyanins.
    

Detailed description: 
      The trial is designed as a randomized 2-arm, placebo-controlled, within-subjects crossover
      utilizing a multiple sampling, repeated measures paradigm to investigate the effects of
      consumption of different types of fruits on cognitive performance and metabolic responses.
      This trial will test 2 treatment conditions in forty men and women who will be enrolled into
      the study.

      Each subject will be asked to come for one screening visit, a pre-study visit, and two dinner
      pick-ups the day before each of the two test visits and 2 test visits. Participation in this
      study will last approximately four weeks.

      The initial screening visit will provide the subject with the informed consent document and
      determine eligibility through anthropometric measurements, vital signs, fasting blood glucose
      test , vein assessment, color test and completion of a survey relate to general eating,
      health, and exercise habits. In addition, subjects will take brief tests of attention and
      memory to ensure capability and willingness to perform tests during subsequent research
      visits. Eligible subjects will be trained and instructed to record all food and beverages
      consumed for a 3-day period (one weekend day and two weekdays) on food record diaries. At the
      pre-study visit, subjects will be instructed to follow a strictly limited polyphenolic diet
      for 7 days prior to the study and throughout their participation time, while maintaining
      their usual diet pattern and physical activity. A dinner meal will be provided the day before
      the study visit.

      At each test visit, subjects will arrive at the clinic after fasting 8 to 12 hours and in a
      well-hydrated state. After confirming compliance with protocol, anthropometric measurements
      and vital signs will be taken along with a finger prick for fasting blood glucose and a
      catheter placement .

      Fasting baseline blood sample from a catheter will be collected after which baseline
      cognitive performance measures will be assessed. After completing baseline measures, subjects
      will receive a standard breakfast meal along with a beverage containing different fruits
      according to the randomization sequence. Additional blood samples will be taken at 30, 60,
      120, 180, 240, 300, 360, and 480 minutes after the start of the breakfast meal. Additional
      cognitive tests will be performed at the 120, 240, 360, and 480 minute time points. A
      standardized lunch will be provided between the 360 and 480 minute time points.

      Subject will come to the clinic for 2 test day visits; all procedures will be the same except
      for the treatment (the test or control treatment).
    

Intervention name(s): Treatment 1; Treatment 2
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Treatment 1 Beverage; Treatment 2 Beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Cognitive performance; Metabolic control; Pharmacokinetic profile; Anthocyanins