- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01507012
The Effect Of Berry Polyphenols On Human Behaviour
A Double Blind, Placebo Controlled Study Measuring The Effect Of Berry Polyphenols On Mood And Cognition In Healthy Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project will investigate the acute effects on human cognitive behaviour and mood of a single consumption of 2 berryfruit drinks (with balanced polyphenol content) versus a placebo. Drinks are matched for taste, sugar content and appearance. Drinks contain natural berry fruit grown and juiced or extracted in New Zealand under food-safe conditions.
The study will follow a double-blind, counterbalanced, placebo controlled, repeated measures design with 36 healthy participants aged between 18 and 30 completing 3 study day sessions as well as one training/screening visit (four visits in total). On one occasion participants will receive a placebo, on another berryfruit drink 1, and on another berryfruit drink 2. Study days will be spaced one week apart to accommodate a wash out period. Both berryfruit drinks will be made to include 500mg of polyphenols/60kg of body weight. Sucralose (artificial sweetener) will be added to make the drinks palatable. Participants will be screened for any intolerance or allergies to the drinks during the training/screening session.
Psychometric tasks and mood scales will be measured using the Computerised Mental Performance Assessment System (COMPASS), a purpose designed software application for the flexible delivery of randomly generated parallel versions of standard and novel cognitive assessment tasks that has previously been shown to be sensitive to nutritional interventions and was used in the prior study conducted at Northumbria University. The cognitive assessment battery will include: Bond-Lader mood scales, visual analogue mood scales, 7 repetitions of Digital Vigilance, Stroop, Rapid Visual Information Processing and Mental Fatigue Visual Analogue scales. This is followed by a logical reasoning task and a final set of the Bond-Lader mood scales.
Baseline cognitive testing will involve one repetition of the cognitive assessment battery (Bond-Lader mood scales, Visual Analogue scales, Digital Vigilance, Stroop and RVIP followed by a second set of Visual Analogue scales).
On all 3 testing days participants will arrive at the lab in the morning (8:30 am), after an overnight fast, and firstly give a 10 mL venous blood sample taken by a trained phlebotomist. Participants will then have their blood glucose measured via a finger prick and heart rate/blood pressure (autonomic measures) measured using an automated digital blood pressure monitor. Participants will then complete one repetition of the COMPASS computerised cognitive assessment battery (baseline). Participants will then be orally supplemented with treatment in the form of a single serve juice drink.
After a 60 minute absorption period, autonomic measurements and a second blood glucose reading will be taken. Participants will then complete the COMPASS assessment. After completion of the assessment, a third set of autonomic measurements will be immediately taken along with a third blood glucose reading and a second 10 mL venous blood sample.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Auckland, New Zealand, 1025
- The New Zealand Institute for Plant & Food Research Ltd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Placebo control containing sugar and artificial flavouring.
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Experimental: Powdered berryfruit extract
Powdered berry extract containing 500mg of polyphenols
|
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Experimental: Berryfruit juice
Berryfruit juice containing 500mg polyphenols
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Attention and vigilance
Time Frame: baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
|
Attention and vigilance will be measured at baseline ad then 1 hour post supplementation of the study treatment.
at baseline the digit vigilance task, stroop task and RVIP task will be completed.
One hour post supplementation of the study treatment, 7 sets of digit vigilance, stroop and RVIP will be completed.
The outcome measures will be treated as change from baseline scores.
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baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
|
Change from baseline blood platelet monoamine oxidase-B activity
Time Frame: Baseline and 150 minutes post dose
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Baseline and 150 minutes post dose
|
|
Change from baseline visual analogue scale fatigue
Time Frame: baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
|
baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
|
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Change from baseline blood glucose mmol/L
Time Frame: Baseline, 60 minutes post dose and 150 minutes post dose
|
Baseline, 60 minutes post dose and 150 minutes post dose
|
|
Change from baseline blood plasma anthocyanin levels
Time Frame: Baseline and 150 minutes post supplementation
|
Baseline and 150 minutes post supplementation
|
|
Change from baseline visual analogue scale difficulty
Time Frame: baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
|
baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.
|
|
Change from baseline Bond Lader mood scales
Time Frame: Baseline, 60 minutes and 1 hour 50 minutes post dose
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Baseline, 60 minutes and 1 hour 50 minutes post dose
|
|
Change from baseline diastolic blood pressure
Time Frame: Baseline, 60 minutes and 150 minutes
|
Baseline, 60 minutes and 150 minutes
|
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Change from baseline systolic blood pressure
Time Frame: Baseline, 60 minutes and 150 minutes post supplementation
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Baseline, 60 minutes and 150 minutes post supplementation
|
|
Change from baseline logical reasoning
Time Frame: Baseline and 150 minutes post supplementation
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Baseline and 150 minutes post supplementation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anthony W Watson, Northumbria University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 28AI1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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