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

Ageing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810769
• Other study ID #: 28AI5
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: June 20, 2016
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2016
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ageing

Intervention

Dietary Supplement:
• Berry drink
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
• Control
Sugar matched control containing berry flavouring and no phytochemicals
• Powdered berry drink
Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols

Locations

Country	Name	City	State
United Kingdom	Brain, Performance and Nutrition Research Centre	Newcastle Upon-Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	The New Zealand Institute for Plant and Food Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose		Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose	No
Primary	Blood lactate		Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose	No
Primary	Monoamine oxidase B inhibition		Change from baseline at 350 minutes post dose	No
Primary	Cognitive Measures - Memory- Assessed using a computerised cognitive batter.		Change from baseline 60, 150, 240 and 360 minutes post dose	No
Primary	Cognitive Measures - Attention- Assessed using a computerised cognitive batter.		Change from baseline 60, 150, 240 and 360 minutes post dose	No

External Links

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