Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters

Early Phase 1

• Conditions: Memory; Gene Expression
• Interventions: Dietary Supplement: bilberry (European blueberries) and red grape juice; Dietary Supplement: placebo juice

• Registration Number: NCT00972972
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

The purpose of this study is to determine whether dietary intervention with blueberry and grape juice extracts in elderly men with subjective memory problems would raise performance on neuropsychological memory tests and change biomarker of muscle damage and whole blood gene expression profiles.

Detailed Description

A number of studies have shown that increased dietary intake of fruits and vegetable extracts high in antioxidants (e.g., blueberries, strawberries and spinach) can retard and even reverse age-related decline in brain function and in cognitive and motor performance in rats. This is the first placebo-controlled human study to evaluate the effect of dietary intake of fruit polyphenols on neuropsychological test scores and whole blood gene regulation

Sixty-two non-demented, non-depressed men (age 67-77 years) with subjective memory decline, were randomly assigned to a blueberry/grape juice- and placebo-group in a 9 week double blind intervention study. Pre- and post treatment assessment were measured with a computerised neuropsychological test battery (CANTAB), including tests for motor speed, visual reaction time, and spatial memory. Dietary habits were registered before intervention and several clinical biomarkers were measured in plasma/serum before and after the intervention. Pre- and post intervention-samples for measurement of gene regulation were also collected

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-07
• Status Verified: 2009-09
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Submitted: 2009-09-11
• Last Update Posted: 2009-09-15
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 61

Inclusion Criteria

• men
• age 67-77 years
• gradual subjective memory decline
• response to advertisement

Exclusion Criteria

• head trauma with loss of consciousness and lasting symptoms
• brain stroke within last 3 years
• dementia, clinically diagnosed
• signs of brain-degenerative disease
• Mini Mental Status Examination score less than 26
• depression (MADRS; Montgomery Asberg Depression Rating Scale score above 20)
• ongoing treatment for cancer (cytostatica)/diabetes
• reported or observed serious mental illness
• reported or observed use of narcotics (any, present or past)
• reported or observed abuse of alcohol
• visual, auditory, or motor handicaps of relevance for performance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary supplement	bilberry (European blueberries) and red grape juice	Extracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.)
placebo dietary supplement	placebo juice	Placebo juice extracts

Primary Outcome Measures

Name	Time	Method
neuropsychological test scores and whole blood gene regulation	December 2006 - july 2007
whole blood gene regulation; parameters in blood	2006 and 2007
neuropsychological test scores; whole blood gene regulation; parameters in blood	2006 and 2007

Secondary Outcome Measures

Name	Time	Method
gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood	2007 and 2009

Trial Locations

Locations (1)

Ulleval University Hospital HF; 🇳🇴 Oslo, Norway