NCT01540123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

February 6, 2012

Last Update Submit

June 20, 2016

Conditions

Cerebral Blood Flow

Outcome Measures

Primary Outcomes (3)

  • Digital Volume Pulse

    Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose

  • Cerebral blood flow

    Continuous measure from baseline to 100 minutes post dose

  • Blood platelet MAO-B activity

    Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose

Study Arms (2)

Control

PLACEBO COMPARATOR

Sugar matched control containing no phytochemicals

Dietary Supplement: Control

Berry drink standardised to contain 500mg of polyphenols

EXPERIMENTAL

Cold pressed berry drink standardised to contain 500mg of berry polyphenols

Dietary Supplement: Berry drink

Interventions

Berry drinkDIETARY_SUPPLEMENT

Cold pressed berry drink standardised to contain 500mg of berry polyphenols

Berry drink standardised to contain 500mg of polyphenols
ControlDIETARY_SUPPLEMENT

Sugar matched control containing berry flavouring and no phytochemicals

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain, Performance and Nutrition Research Centre

Newcastle upon Tyne, Newcastle Upon-Tyne, NE18ST, United Kingdom

Location

Related Publications (1)

  • Watson AW, Scheepens A, Kennedy DO, Haskell-Ramsay CF. Effects of blackcurrant juice on pre-frontal cortical haemodynamics and cognition in healthy young adults. Nutr Neurosci. 2026 Jan;29(1):14-28. doi: 10.1080/1028415X.2025.2538062. Epub 2025 Sep 25.

    PMID: 40999681DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 28, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

GB(1)