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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02985580
Other study ID # 1314/134617
Secondary ID
Status Completed
Phase N/A
First received September 13, 2016
Last updated December 2, 2016
Start date October 2013
Est. completion date September 2014

Study information

Verified date September 2016
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority UK: University of Exeter
Study type Interventional

Clinical Trial Summary

Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective. The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse. We therefore investigated whether 12 weeks of blueberry concentrate supplementation improved cognitive function in healthy elderly via increased brain activation and perfusion.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- aged 60-80y

- Addenbrooke's Cognitive Examination III questionnaire > 88

- Consuming 5 or less portions of fruit per day

Exclusion Criteria:

Addenbrooke's Cognitive Examination III questionnaire < 88 Contraindications for MRI Consuming more than 5 portions of fruit per day

Study Design

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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Blueberry

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Outcome

Type Measure Description Time frame Safety issue
Primary Brain perfusion MRI - arterial spin labelling Change from baseline to 12 weeks dietary supplementation No
Secondary Brain activation fMRI whilst performing modified Stroop task Change from baseline to 12 weeks dietary supplementation No
Secondary Cognitive function tests Cogstate battery of tests Change from baseline to 12 weeks dietary supplementation No
Secondary Blood biomarkers of inflammation CRP, IL6, Change from baseline to 12 weeks dietary supplementation No
Secondary Blood biomarkers of oxidative stress protein carbonyls, glutathione Change from baseline to 12 weeks dietary supplementation No
Secondary Blood biomarkers of neurogenesis BDNF Change from baseline to 12 weeks dietary supplementation No
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