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

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ClinicalTrials.gov Identifier: NCT02810769
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
The New Zealand Institute for Plant and Food Research
Information provided by (Responsible Party):
Anthony Watson, Northumbria University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ageing Dietary Supplement: Berry drink Dietary Supplement: Control Dietary Supplement: Powdered berry drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Placebo Comparator: Control
Sugar matched control containing no phytochemicals
Dietary Supplement: Control
Sugar matched control containing berry flavouring and no phytochemicals

Experimental: Juiced berry drink
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
Dietary Supplement: Berry drink
Cold pressed berry drink standardised to contain 500mg of berry polyphenols

Experimental: Powdered berry drink
Berry drink made up from a powdered concentrate. each drink will be standardised to contain 500mg of polyphenols
Dietary Supplement: Powdered berry drink
Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810769


Locations
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United Kingdom
Brain, Performance and Nutrition Research Centre
Newcastle Upon-Tyne, United Kingdom, NE18ST
Sponsors and Collaborators
Northumbria University
The New Zealand Institute for Plant and Food Research
Additional Information:
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Responsible Party: Anthony Watson, Principal Investigator, Northumbria University
ClinicalTrials.gov Identifier: NCT02810769    
Other Study ID Numbers: 28AI5
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016