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

June 20, 2016 updated by: Anthony Watson, Northumbria University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle Upon-Tyne, United Kingdom, NE18ST
        • Brain, Performance and Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Digital Volume Pulse
Time Frame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
Cerebral blood flow
Time Frame: Continuous measure from baseline to 100 minutes post dose
Continuous measure from baseline to 100 minutes post dose
Blood platelet MAO-B activity
Time Frame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

The New Zealand Institute for Plant and Food Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 28AI3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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