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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01507012




Registration number
NCT01507012
Ethics application status
Date submitted
20/09/2011
Date registered
10/01/2012
Date last updated
10/01/2012

Titles & IDs
Public title
The Effect Of Berry Polyphenols On Human Behaviour
Scientific title
A Double Blind, Placebo Controlled Study Measuring The Effect Of Berry Polyphenols On Mood And Cognition In Healthy Adults
Secondary ID [1] 0 0
28AI1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Placebo

Experimental: Powdered berryfruit extract - Powdered berry extract containing 500mg of polyphenols

Placebo comparator: Placebo -

Experimental: Berryfruit juice - Berryfruit juice containing 500mg polyphenols


Treatment: Other: Placebo
Placebo control containing sugar and artificial flavouring.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline Attention and vigilance
Timepoint [1] 0 0
baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
Primary outcome [2] 0 0
Change from baseline blood platelet monoamine oxidase-B activity
Timepoint [2] 0 0
Baseline and 150 minutes post dose
Primary outcome [3] 0 0
Change from baseline visual analogue scale fatigue
Timepoint [3] 0 0
baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
Primary outcome [4] 0 0
Change from baseline blood glucose mmol/L
Timepoint [4] 0 0
Baseline, 60 minutes post dose and 150 minutes post dose
Primary outcome [5] 0 0
Change from baseline blood plasma anthocyanin levels
Timepoint [5] 0 0
Baseline and 150 minutes post supplementation
Primary outcome [6] 0 0
Change from baseline visual analogue scale difficulty
Timepoint [6] 0 0
baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
Primary outcome [7] 0 0
Change from baseline Bond Lader mood scales
Timepoint [7] 0 0
Baseline, 60 minutes and 1 hour 50 minutes post dose
Primary outcome [8] 0 0
Change from baseline diastolic blood pressure
Timepoint [8] 0 0
Baseline, 60 minutes and 150 minutes
Primary outcome [9] 0 0
Change from baseline systolic blood pressure
Timepoint [9] 0 0
Baseline, 60 minutes and 150 minutes post supplementation
Primary outcome [10] 0 0
Change from baseline logical reasoning
Timepoint [10] 0 0
Baseline and 150 minutes post supplementation

Eligibility
Key inclusion criteria
* MMale/female,
* Healthy Age 18-35 years old
* Non smoker
* Proficient in English
* Not taking any herbal or prescription medications
* Not pregnant or seeking to become pregnant, BMI < 30kg/m2
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Tobacco user,
* pregnant or seeking to become 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Northumbria University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The New Zealand Institute for Plant and Food Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Polyphenols, compounds found at high levels in berry fruit, have been shown to have health promoting benefits through various mechanisms both in vivo and in vitro. These benefits include antioxidant activity, anti-inflammatory properties, and monoamine oxidase (MAO) inhibition. This study aims to expand on the extremely promising animal data in the literature, and our own pilot study results, to investigate whether drinks containing berry fruit can improve cognitive performance and mood in healthy human participants.

Our central hypothesis is that fruit extracts can reduce the breakdown of neurotransmitters such as dopamine and serotonin. This reduction in breakdown could therefore increase the levels of these neurotransmitters and convey some benefits in regards to mood and cognitive function. The investigators will assess the pharmacokinetic activity of berry fruit extracts on MAO activity to test this hypothesis.

A second hypothesis is that berryfruit polyphenols may alter circulating levels of glucose that may in turn affect cognitive performance and mood.

A prior study carried out by Plant \& Food Research through collaboration with the University of Northumbria, UK, found promising results after acutely supplementing participants with a berry fruit based drink. This study aims to use the results from the previous study to assess in depth the effect of berry fruit drinks on human behaviour.
Trial website
https://clinicaltrials.gov/study/NCT01507012
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony W Watson
Address 0 0
Northumbria University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01507012