NCT02985580

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
Last Updated

December 7, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

September 13, 2016

Last Update Submit

December 2, 2016

Conditions

Cognitive Aging

Outcome Measures

Primary Outcomes (1)

  • Brain perfusion

    MRI - arterial spin labelling

    Change from baseline to 12 weeks dietary supplementation

Secondary Outcomes (5)

  • Brain activation

    Change from baseline to 12 weeks dietary supplementation

  • Cognitive function tests

    Change from baseline to 12 weeks dietary supplementation

  • Blood biomarkers of inflammation

    Change from baseline to 12 weeks dietary supplementation

  • Blood biomarkers of oxidative stress

    Change from baseline to 12 weeks dietary supplementation

  • Blood biomarkers of neurogenesis

    Change from baseline to 12 weeks dietary supplementation

Study Arms (2)

Blueberry

ACTIVE COMPARATOR

Blueberry concentrate consumed daily for 12 weeks.

Dietary Supplement: Blueberry

Placebo

PLACEBO COMPARATOR

Placebo concentrate consumed daily for 12 weeks.

Dietary Supplement: Placebo

Interventions

BlueberryDIETARY_SUPPLEMENT
Blueberry
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60-80y
  • Addenbrooke's Cognitive Examination III questionnaire \> 88
  • Consuming 5 or less portions of fruit per day

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

blueberry extract

Study Officials

  • Joanna Bowtell, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

December 7, 2016

Study Start

October 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share