The Effect Of Berry Polyphenols On Human Behaviour

NCT01507012 | Completed

• 1 other identifier: 28AI1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Berry phenolics; mood; cognition; adults

Outcome Measures

Primary Outcomes (10)

• Change from Baseline Attention and vigilance

  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.

  baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.

• Change from baseline blood platelet monoamine oxidase-B activity

  Baseline and 150 minutes post dose

• Change from baseline visual analogue scale fatigue

  baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.

• Change from baseline blood glucose mmol/L

  Baseline, 60 minutes post dose and 150 minutes post dose

• Change from baseline blood plasma anthocyanin levels

  Baseline and 150 minutes post supplementation

• Change from baseline visual analogue scale difficulty

  baseline, 1 hour post dose then incrementally every 10 minutes for 70 minutes.

• Change from baseline Bond Lader mood scales

  Baseline, 60 minutes and 1 hour 50 minutes post dose

• Change from baseline diastolic blood pressure

  Baseline, 60 minutes and 150 minutes

• Change from baseline systolic blood pressure

  Baseline, 60 minutes and 150 minutes post supplementation

• Change from baseline logical reasoning

  Baseline and 150 minutes post supplementation

Study Arms (3)

Powdered berryfruit extract

EXPERIMENTAL

Powdered berry extract containing 500mg of polyphenols

Dietary Supplement: Berry Polyphenols

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Berryfruit juice

EXPERIMENTAL

Berryfruit juice containing 500mg polyphenols

Dietary Supplement: Berry Polyphenols

Interventions

Berry Polyphenols DIETARY_SUPPLEMENT

Berryfruit juice; Powdered berryfruit extract

Placebo DIETARY_SUPPLEMENT

Placebo control containing sugar and artificial flavouring.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• The New Zealand Institute of Plant and Food Research Ltd.: collaborator

Study Sites (1)

The New Zealand Institute for Plant & Food Research Ltd

Auckland, 1025, New Zealand

Location

Study Officials

• Anthony W Watson

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: January 10, 2012
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

NZ (1)