The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60
1 other identifier
interventional
36
1 country
1
Brief Summary
The first study of my PhD showed that acute supplementation of berry extracts can modulate cognitive behaviour in healthy adults. There is a growing body of evidence supporting an improvement in memory and learning performance in animal models following the ingestion of flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However, study 2, showed no effect on any aspects of memory in healthy young adults after supplementation of the berry extracts. It is hypothesised that the lack of behavioural effects on memory of the berry juice in study 2 was because of the cohort used. These healthy adult participants were already performing near to their peak (Salthouse et al., 2009), and unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive benefits. The aims of the study are to examine if acute supplementation of two berry extracts in an older population can augment memory, attention and executive function. Secondly, the time course of these behavioural effects will be measured by multiple cognitive assessments throughout the day after consumption of the extracts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
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
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedJune 23, 2016
June 1, 2016
6 months
November 8, 2012
June 20, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
Blood glucose
Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
Blood lactate
Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
Monoamine oxidase B inhibition
Change from baseline at 350 minutes post dose
Cognitive Measures - Memory- Assessed using a computerised cognitive batter.
Change from baseline 60, 150, 240 and 360 minutes post dose
Cognitive Measures - Attention- Assessed using a computerised cognitive batter.
Change from baseline 60, 150, 240 and 360 minutes post dose
Study Arms (3)
Control
PLACEBO COMPARATORSugar matched control containing no phytochemicals
Juiced berry drink
EXPERIMENTALCold pressed berry drink standardised to contain 500mg of berry polyphenols
Powdered berry drink
EXPERIMENTALBerry drink made up from a powdered concentrate. each drink will be standardised to contain 500mg of polyphenols
Interventions
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
Sugar matched control containing berry flavouring and no phytochemicals
Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols
Eligibility Criteria
You may qualify if:
- Healthy
- Non-smokers
- Aged between 40 and 60 years
You may not qualify if:
- History of neurological, vascular or psychiatric illness.
- BMI greater than 35 kg/m2
- 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, or have taken in the last 2 weeks, any prescribed, illicit or herbal drugs and food supplements.
- Any known active infections.
- HIV antibody positive.
- +7 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
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
November 8, 2012
First Posted
June 23, 2016
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 23, 2016
Record last verified: 2016-06