Clinical trial NCT02810769: The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60
Official title: The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: The New Zealand Institute of Plant and Food Research Ltd.
First posted: 2016-06-23
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Blood glucose
timeFrame: Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
measure: Blood lactate
timeFrame: Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
measure: Monoamine oxidase B inhibition
timeFrame: Change from baseline at 350 minutes post dose
measure: Cognitive Measures - Memory- Assessed using a computerised cognitive batter.
timeFrame: Change from baseline 60, 150, 240 and 360 minutes post dose
measure: Cognitive Measures - Attention- Assessed using a computerised cognitive batter.
timeFrame: Change from baseline 60, 150, 240 and 360 minutes post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon-Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Research Centre
Study officials:
References: