The Time Effects of a Berry Extract Upon Cerebral Blood Flow.

This study is currently recruiting participants.
Verified November 2012 by Northumbria University
Sponsor:
Collaborator:
The New Zealand Institute for Plant and Food Research
Information provided by (Responsible Party):
Anthony Watson, Northumbria University
ClinicalTrials.gov Identifier:
NCT01540123
First received: February 6, 2012
Last updated: November 23, 2012
Last verified: November 2012

February 6, 2012
November 23, 2012
February 2012
May 2013   (final data collection date for primary outcome measure)
  • Digital Volume Pulse [ Time Frame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose ] [ Designated as safety issue: No ]
  • Cerebral blood flow [ Time Frame: Continuous measure from baseline to 100 minutes post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540123 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Time Effects of a Berry Extract Upon Cerebral Blood Flow.
The Time Effects of a Berry Extract Upon Cerebral Blood Flow.

Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties.

Despite the wide health promoting properties of fruit extracts reported in the literature, considerable interest over the past decade has primarily been focused on their roles in reducing risk factors associated with cancer and heart disease. Consequently, there remains a paucity of actual scientific information on their role in modulating brain functions, such as mood, learning and memory, any decrements of which have very negative impacts on the quality of life.

Fruit phytochemicals from other sources have been shown to mediate both peripheral and cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of oxygen and glucose as well as the removal of waste products. The modulation of cerebral blood flow via supplementation of berry polyphenols could therefore be a potential way to positively modulate human cognitive behavior. The link between acute increases in cerebral blood flow and increased cognition is currently a little weak but it could give a good platform for long term behavioral and health benefits via increased cerebral/peripheral blood flow and decreased MAO-B activity.

The aims of the study are therefore to investigate the impact of the berry extract on digital volume pulse, blood pressure and cerebral blood flow.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Cerebral Blood Flow
  • Dietary Supplement: Berry drink
    Cold pressed berry drink standardised to contain 500mg of berry polyphenols
  • Dietary Supplement: Control
    Sugar matched control containing berry flavouring and no phytochemicals
  • Placebo Comparator: Control
    Sugar matched control containing no phytochemicals
    Intervention: Dietary Supplement: Control
  • Experimental: Berry drink standardised to contain 500mg of polyphenols
    Cold pressed berry drink standardised to contain 500mg of berry polyphenols
    Intervention: Dietary Supplement: Berry drink
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy
  • none smokers
  • aged between 18 and 35 years

Exclusion Criteria:

  • History of neurological, vascular or psychiatric illness.
  • Current diagnosis of depression and/or anxiety.
  • History or current diagnosis of drug/alcohol abuse.
  • Anaemia.
  • Any heart disorder.
  • Hypertension
  • Any respiratory disorder.
  • Diabetes.
  • Food intolerances/sensitivities.
  • Phenylketonuria.
  • Use tobacco products or have ceased in the last 6 months.
  • Currently taking any prescribed, illicit or herbal drugs.
  • Any known active infections.
  • HIV antibody positive.
  • Currently have, have ever had, or may be at risk of hepatitis.
  • Have suffered from jaundice within the last year.
  • Have haemophilia or any similar clotting disorder.
  • History of head trauma
  • History of migraines
  • History of learning difficulties
  • Any Issues with giving blood samples.
Both
18 Years to 35 Years
Yes
Not Provided
United Kingdom
 
NCT01540123
28AI3
Yes
Anthony Watson, Northumbria University
Northumbria University
The New Zealand Institute for Plant and Food Research
Not Provided
Northumbria University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP