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

Cerebral Blood Flow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540123
• Other study ID #: 28AI3
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: June 20, 2016
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2016
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cerebral Blood Flow

Intervention

Dietary Supplement:
• Berry drink
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
• Control
Sugar matched control containing berry flavouring and no phytochemicals

Locations

Country	Name	City	State
United Kingdom	Brain, Performance and Nutrition Research Centre	Newcastle Upon-Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	The New Zealand Institute for Plant and Food Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digital Volume Pulse		Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose	No
Primary	Cerebral blood flow		Continuous measure from baseline to 100 minutes post dose	No
Primary	Blood platelet MAO-B activity		Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose	No

External Links

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