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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Cerebral Blood Flow
Dietary Supplement: Berry drink
Dietary Supplement: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Time Effects of a Berry Extract Upon Cerebral Blood Flow.

Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Sugar matched control containing no phytochemicals
Dietary Supplement: Control
Sugar matched control containing berry flavouring and no phytochemicals
Experimental: Berry drink standardised to contain 500mg of polyphenols
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
Dietary Supplement: Berry drink
Cold pressed berry drink standardised to contain 500mg of berry polyphenols

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540123

Locations
United Kingdom
Brain, Performance and Nutrition Research Centre Recruiting
Newcastle Upon-Tyne, United Kingdom, NE18ST
Contact: Anthony W Watson    0191274468 ext 4468    Anthony2.watson@northumbria.ac.uk   
Sub-Investigator: Anthony W Watson         
Sponsors and Collaborators
Northumbria University
The New Zealand Institute for Plant and Food Research
  More Information

Additional Information:
No publications provided

Responsible Party: Anthony Watson, Principal Investigator, Northumbria University
ClinicalTrials.gov Identifier: NCT01540123     History of Changes
Other Study ID Numbers: 28AI3
Study First Received: February 6, 2012
Last Updated: November 23, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on July 20, 2014