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Mechanistic Assessment of the Acute and Chronic Cognitive Effects of Flavanol/Anthocyanin Intervention in Humans - Chronic Trial (NCT03030053)

Mars, Inc.
Biotechnology and Biological Sciences Research Council
A double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy older adults will be conducted to determine the effect of a flavonoid-rich supplement on cognitive function, peripheral arterial health and brain mechanisms. It is predicted that chronic flavonoid supplementation will result in cognitive benefits and that these may be due to beneficial effects of flavonoids on vascular and brain function.
  • : Cocoa-Flavanol Supplements
    3 capsules each containing 300mg cocoa flavanols (total daily dose of 900mg cocoa-flavanols).
    • : Control Supplements
      3 capsules each containing 0mg cocoa-flavanols
      Ages eligible for Study
      60 Years to 75 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      Accepts Healthy Volunteers
      There has recently been an increasing interest in the potential of flavonoids, plant derived compounds found in foods such as fruit and vegetables, to improve cognitive function. Research suggests that flavonoids improve memory and learning, possibly as a result of their anti-inflammatory and neuroprotective effects, for example by increasing cerebral blood flow (CBF), protecting vulnerable neurons, or by stimulating neuronal function and growth. The proposed research will involve a parallel design chronic dietary supplementation trial using a flavonoid-supplement and a matched control containing no flavonoids, to investigate long-term changes in cognitive performance. To understand the neural mechanisms behind potential changes in cognitive performance, resting cerebral blood flow (CBF), blood-oxygen level dependent (BOLD) response during two sensitive tests of cognitive performance, and structural brain changes will be measured in a group of healthy elderly adults (N=70, age range 60-75 years) using magnetic resonance imaging (MRI). Additionally, peripheral vascular health will be measured using flow mediated dilatation (FMD), and bioavailability of flavonoid monomers and metabolites will be determined through analysis of plasma and urine samples. Biomarkers in the blood associated with vascular health and neural functioning as well as markers of interest in relation to the possible mechanisms of action of flavonoids will also be measured. All endpoints will be acquired before and after a 24-week chronic supplementation of either a high flavonoid supplementation or a control product, consumed in addition to participants' normal diet. Measures will also be taken following a 12-week post-intervention washout period in order to investigate whether any beneficial effects are sustained following cessation of supplementation.

      1 locations

      United Kingdom (1)
      • Hugh Sinclair Unit of Human Nutrition, University of Reading
        recruiting
        Reading, Berkshire, United Kingdom, RG6 5SG
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 January, 2016
      Updated:
      19 February, 2017
      Participants:
      70
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