Blueberry Study Aimed at Improving Cognition and Peripheral Blood Flow
Condition: Vascular Stiffness; Cognitive Change; Blood Pressure
Study type: Interventional

Summary: 
      Blueberries are rich in the content of a variety of biologically active chemicals that
      contribute to their health properties. The consumption of blueberries has beneficial effects
      on vascular function and brain health and function. Blueberries are present in human diet in
      a number of forms, but the investigator do not know which form is best for health and why
      people respond differently to eating blueberries.

      The aim of the present study is to assess the effects of 1 week's supplementation of whole
      blueberries or freeze-dried blueberry powder or encapsulated blueberry components on vascular
      function and brain health and function. Investigators will then categorise participants as
      those who have large effects of the intervention (responders) and those that don't show much
      effect at all (non-responders). Then the investigators will look into the role that genes
      play in this response and determine if metabolism is similar in these groups of participants.
      Any changes in participants' brain health and vascular function will be linked to these
      metabolic and genomic pathways, and this will help the investigators to further understand
      how blueberry consumption can benefit human health.
    

Detailed description: 
      Study design: The present study will supply either 160 g of fresh whole blueberry (4 handful
      portion) or 20 g of freeze-dried blueberry powder (measured with tablespoon provided;
      equivalent to 160 g of whole fresh blueberry), or placebo capsule with only microcrystalline
      cellulose (approx. 10 g, they will be blinded that this is encapsulated blueberry extract
      components) to 80 subjects on separate occasions with age range of 18-60 years old for 1 week
      with 1 week of washout period. Fresh blueberries will be purchased from local supermarkets;
      freeze-dried blueberry powder will be purchased from Lio-Licious freeze-dried fruits range;
      the microcrystalline cellulose will be purchased from Blackburn Distributions. There is no
      outside interest that could constitute commercial conflict of interest.

      Methodology and sampling strategy: a randomised crossover design will be implemented. The
      study is a quantitative experiment and participants will be recruited through opportunity
      sampling.

      Data collection: On each visit, cognition data will be obtained from computerised testing
      system COMPASS. Blood pressure will be obtained using fully automatic oscillometric device.
      On visits 2-7, PWV value is obtained by SphygmoCor; untargeted metabolomics and genomic data
      will be obtained from blood and urine sample collection.

      For data analysis: The identification of responders to the treatments will be done by the
      calculation of response level first: response level = (change from baseline score/baseline
      score) x 100%. The calculated percentage will be used to characterise subjects from lowest
      response to highest response level. The association among -omics biomarkers and cognitive
      tests/endothelial parameters, lipid status under each treatment will be analysed using linear
      regression models after adjusting for confounding factors like age. Pathway analysis will be
      used to identify metabolic pathways that characterise responders and non-responders. Pathways
      will be identified using discriminatory metabolites from metabolomics and SNP analysis.
    

Intervention name(s): Blueberries; Blueberry powder; Blueberry components capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): fresh spanish blueberries; freeze-dried blueberry powder; encapsulated blueberry components (microcrystalline cellulose powder in actual)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: blueberry; intervention; endothelial function; cognition; metabolomics; genomics