Multi Dose Effects of a Berry Extract Upon Moodand Cognition in Healthy Young Adults
1 other identifier
interventional
36
1 country
1
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. A prior study carried out as the first study of my PhD, attempted to bridge this gap in knowledge and found promising results after acutely supplementing participants with a fruit based drink. The findings showed that there was an increased vigilance on attention related psychometric tasks and an increased feeling of calmness. The investigators have hypothesised that these cognitive enhancing effects are due to the monoamine oxidase (MAO) inhibiting effect of the fruit drink, our ex vivo findings support this with a 96% reduction in MAO-B activity. The aims of the current study are threefold: to extend the findings of my previous investigation by extending the tasks explored; to ascertain if the positive results of the first study are dose dependent; and to investigate whether a lower dose can facilitate greater changes in behaviour.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 17, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedMay 25, 2012
May 1, 2012
7 months
May 17, 2012
May 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in cognition
baseline, 1 hour post dose and 2 hours 30mins post dose.
Change in mood
Baseline, 1 hour post dose and 2 hours 30mins post dose.
Change in Monoamine Oxidase-B activity
baseline and 2 hours post dose
Secondary Outcomes (1)
Change in prolactin
baseline and 2 hours post dose
Study Arms (4)
Berry extract 125
EXPERIMENTALFresh berry extract containing 125mg of polyphenols
Berry extract 250
EXPERIMENTALFresh berry extract containing 250mg of polyphenols
Berry extract 500
EXPERIMENTALFresh berry extract containing 500mg of polyphenols
Placebo
PLACEBO COMPARATORBerry flavoured juice containing no polyphenols
Interventions
Fresh berry extract containing 500mg, 250mg, 125mg per 60 kilos of body weight. Or placebo.
Eligibility Criteria
You may qualify if:
- Healthy
- aged between 18-35 years old,
- non smokers,
- bmi \< 30kg/m2
You may not qualify if:
- smoker,
- pregnant,
- currently taking recreational over the counter/prescription medication (excluding the contraceptive pill) and/or dietary/herbal supplements.
- food allergies or sensitivities that are relevant to the study,
- learning difficulties,
- ADHD,
- dyslexia,
- migraines or
- any gastric problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Brain Performance and Nutrition Research Center
Newcastle upon Tyne, NE21 8ST, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony w Watson
Northumbria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2012
First Posted
May 25, 2012
Study Start
July 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 25, 2012
Record last verified: 2012-05