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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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01507012