Healthy Adults. Clinical Trial
Official title:
A Controlled, Cross-over, Acute Intervention Study Investigating the Cognitive and Neuronal Effects of Flavonoids in Blueberries.
| Verified date | February 2013 |
| Source | University of Reading |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | England: University of Reading |
| Study type | Interventional |
This study was a controlled, cross-over, acute flavonoid intervention trial with younger and
older adults. Subjects consumed a blueberry beverage during one visit and a control beverage
on another. Cognitive function pre drink was assessed, blood and urine samples were taken as
well as blood pressure and a measure of vascular reactivity. These outcome measures were
taken at 2 and 5 hours post drink.
It was predicted that the flavonoids in the blueberry drink would lead to improved
performance on the cognitive tests and vascular reactivity measure compared to following the
control drink. It was thought this could be due to increased vaso-dilation and improving
blood flow to the brain which was investigated in an extension to the project where a sample
of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a
control drink.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - No medical conditions - Not taking any medication or supplements (or willing to stop taking supplements for duration of study) - Not lactose intolerant - Willing to give blood and urine samples - Not partaking in frequent vigorous exercise - Not suffering from or history of depression Exclusion Criteria: - On blood pressure medication, taking Aspirin or other blood thinning medication - BMI > 30 - Cholesterol > 6 - Diabetes or other serious medical condition - Lactose intolerant - Any learning difficulty e.g. dyslexia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Reading | Reading | Berkshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Reading |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cognitive function | Extensive cognitive test battery including tasks measuring executive function such as updating, and memory tests such as free recall. | pre drink, 2 hours and 5 hours post drink | No |
| Secondary | Bioavailability and pharmacology | Flavonoid and BDNF levels in plasma and urine samples. | Pre drink and 1 hour post drink | No |
| Secondary | Vascular Reactivity | Measurements taken using Digital volume pulse equipment. Blood pressure also recorded. | Pre and 1 hour post drink | No |
| Secondary | Neuronal effects | Using fMRI to determine whether flavonoid supplementation leads to greater activation in brain regions associated with the cognitive abilities tested and to calculate cerebral blood flow before and after the blueberry compared to the control drink. | Pre and 1 hours post drink | No |