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

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters in Normal, Aged Men With Subjective Memory Decline

Conditions
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Memory, Gene Expression

Intervention / Treatment
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* Dietary Supplement: bilberry (European blueberries) and red grape juice
* Dietary Supplement: placebo juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 67 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dietary supplement<br>Extracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.) | Dietary Supplement: bilberry (European blueberries) and red grape juice<br>* Intervention juice: 50/50 combination of 300 ml bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.) per day for 9 weeks<br>* Other names: polyphenols;|
| Placebo Comparator: placebo dietary supplement<br>Placebo juice extracts | Dietary Supplement: placebo juice<br>* Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood |  | 2007 and 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fruit polyphenols, phytochemicals, neurocognition, neuropsychology, psychopharmacology, gene expression, biochemistry