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Completed

NCT Number: NCT02810769

The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60

The first study of my PhD showed that acute supplementation of berry extracts can modulate cognitive behaviour in healthy adults. There is a growing body of evidence supporting an improvement in memory and learning performance in animal models following the ingestion of flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However, study 2, showed no effect on any aspects of memory in healthy young adults after supplementation of the berry extracts. It is hypothesised that the lack of behavioural effects on memory of the berry juice in study 2 was because of the cohort used. These healthy adult participants were already performing near to their peak (Salthouse et al., 2009), and unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive benefits.

The aims of the study are to examine if acute supplementation of two berry extracts in an older population can augment memory, attention and executive function. Secondly, the time course of these behavioural effects will be measured by multiple cognitive assessments throughout the day after consumption of the extracts.

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Key information

Conditions

Ageing

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain, Performance and Nutrition Research Centre

Newcastle upon Tyne, Newcastle Upon-Tyne, NE18ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • Non-smokers
  • Aged between 40 and 60 years

Exclusion criteria

  • History of neurological, vascular or psychiatric illness.
  • BMI greater than 35 kg/m2
  • Current diagnosis of depression and/or anxiety.
  • History or current diagnosis of drug/alcohol abuse.
  • Anaemia.
  • Any heart disorder.
  • Hypertension
  • Any respiratory disorder.
  • Diabetes.
  • Food intolerances/sensitivities.
  • Phenylketonuria.
  • Use tobacco products or have ceased in the last 6 months.
  • Currently taking, or have taken in the last 2 weeks, any prescribed, illicit or herbal drugs and food supplements.
  • Any known active infections.
  • HIV antibody positive.
  • Currently have, have ever had, or may be at risk of hepatitis.
  • Have suffered from jaundice within the last year.
  • Have haemophilia or any similar clotting disorder.
  • History of head trauma
  • History of migraines
  • History of learning difficulties
  • Any Issues with giving blood samples.

Treatment and study plan

Berry drink

Dietary Supplement

Cold pressed berry drink standardised to contain 500mg of berry polyphenols

Control

Dietary Supplement

Sugar matched control containing berry flavouring and no phytochemicals

Powdered berry drink

Dietary Supplement

Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols

Primary outcomes

  1. Blood glucose

    Time frame: Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose

  2. Blood lactate

    Time frame: Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose

  3. Monoamine oxidase B inhibition

    Time frame: Change from baseline at 350 minutes post dose

  4. Cognitive Measures - Memory- Assessed using a computerised cognitive batter.

    Time frame: Change from baseline 60, 150, 240 and 360 minutes post dose

  5. Cognitive Measures - Attention- Assessed using a computerised cognitive batter.

    Time frame: Change from baseline 60, 150, 240 and 360 minutes post dose

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • The New Zealand Institute of Plant and Food Research Ltd.

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2016
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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