- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Newcastle Upon-Tyne, United Kingdom, NE18ST
- Brain, Performance and Nutrition Research Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Sugar matched control containing no phytochemicals
|
Sugar matched control containing berry flavouring and no phytochemicals
|
Experimental: Juiced berry drink
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
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Cold pressed berry drink standardised to contain 500mg of berry polyphenols
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Experimental: Powdered berry drink
Berry drink made up from a powdered concentrate.
each drink will be standardised to contain 500mg of polyphenols
|
Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood glucose
Time Frame: Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
|
Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
|
Blood lactate
Time Frame: Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
|
Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose
|
Monoamine oxidase B inhibition
Time Frame: Change from baseline at 350 minutes post dose
|
Change from baseline at 350 minutes post dose
|
Cognitive Measures - Memory- Assessed using a computerised cognitive batter.
Time Frame: Change from baseline 60, 150, 240 and 360 minutes post dose
|
Change from baseline 60, 150, 240 and 360 minutes post dose
|
Cognitive Measures - Attention- Assessed using a computerised cognitive batter.
Time Frame: Change from baseline 60, 150, 240 and 360 minutes post dose
|
Change from baseline 60, 150, 240 and 360 minutes post dose
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 28AI5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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