Clinical trial NCT01540123: The Time Effects of a Berry Extract Upon Cerebral Blood Flow.
Official title: The Time Effects of a Berry Extract Upon Cerebral Blood Flow.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Blood Flow
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: The New Zealand Institute of Plant and Food Research Ltd.
First posted: 2012-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Digital Volume Pulse
timeFrame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
measure: Cerebral blood flow
timeFrame: Continuous measure from baseline to 100 minutes post dose
measure: Blood platelet MAO-B activity
timeFrame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon-Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Research Centre
Study officials:
References: