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Multi Dose Effects of a Berry Extract Upon Mood, Attention and Memory in Healthy Young Adults.


N/A
18 Years
35 Years
Not Enrolling
Both
Healthy

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Trial Information

Multi Dose Effects of a Berry Extract Upon Mood, Attention and Memory in Healthy Young Adults.


The project will investigate the acute effects on human cognitive behaviour and mood of a
single consumption of 3 fruit drinks versus a placebo. Drinks will be matched for volume,
taste, appearance and sugars but will differ in the amount of total polyphenols. The 3
active treatment drinks contain a natural berry fruit grown in New Zealand by Plant and Food
Research from commercial cultivars.

The study will follow a double-blind, counterbalanced, placebo controlled, repeated
measures, crossover design with 36 healthy participants aged between 18 and 35 completing
four study day sessions as well as one training/screening visit (five visits in total). On
one occasion participants will receive a placebo, on another fruit drink 1, on another fruit
drink 2 and on another fruit drink 3. Study days will be spaced one week apart to
accommodate a wash out period. Fruit drinks will be made to include 500mg, 250mg or 125mg 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 . Trait anxiety will also be assessed during
the screening visit using the State-Trait Anxiety inventory (STAI - Spielberger, 1966).

Psychometric tasks and mood scales will be delivered 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. .

Baseline cognitive testing will involve the dual task, Digit vigilance, Digit vigilance
fast, Visual analogue scales, 3-back, corsi blocks, simple reaction time, telephone number
task, word recognition, word recall, Bond-Lader mood scales and the state anxiety
questionnaire (STAI).

Baseline On all 3 testing days participants will arrive at the lab in the morning (8:00 am),
after an overnight fast, and firstly give a 10 mL venous blood sample taken by a trained
phlebotomist. 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 (200ml per 60kg weight).

Post Supplementation 60 minutes after supplementation, the first post dose state anxiety
questionnaire will be completed. Participants will then complete the first post dose COMPASS
assessment. After completion of the assessment participants will immediately give a second
10 ml venous blood sample. Participants will then have a 20 minute break before completing
the second post dose COMPASS assessment and complete a final post dose state anxiety
questionnaire.


Inclusion Criteria:



- Healthy

- aged between 18-35 years old,

- non smokers,

- bmi < 30kg/m2

Exclusion Criteria:

- smoker,

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

Change in cognition

Outcome Time Frame:

baseline, 1 hour post dose and 2 hours 30mins post dose.

Safety Issue:

No

Principal Investigator

Anthony w Watson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northumbria University

Authority:

United Kingdom: Research Ethics Committee

Study ID:

28AI2

NCT ID:

NCT01605682

Start Date:

July 2011

Completion Date:

February 2012

Related Keywords:

  • Healthy
  • effect of different berry doses on mood and cognition
  • adults

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