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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2007

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

Interventions

  • Dietary Supplement: bilberry (European blueberries) and red grape juice
    • 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
  • Dietary Supplement: placebo juice
    • Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates

Arms, Groups and Cohorts

  • Active Comparator: dietary supplement
    • Extracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.)
  • Placebo Comparator: placebo dietary supplement
    • Placebo juice extracts

Clinical Trial Outcome Measures

Primary Measures

  • neuropsychological test scores and whole blood gene regulation
    • Time Frame: December 2006 – july 2007
  • whole blood gene regulation; parameters in blood
    • Time Frame: 2006 and 2007
  • neuropsychological test scores; whole blood gene regulation; parameters in blood
    • Time Frame: 2006 and 2007

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 67 Years

Maximum Age: 77 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ullevaal University Hospital
  • Collaborator
    • University of Oslo
  • Provider of Information About this Clinical Study
    • Ulleval University Hospital, Ulleval University Hospital
  • Overall Official(s)
    • KJELL – FLEKKOY, DR. PHILOS., Principal Investigator, ULLEVAAL UNIVERSITY HOSPITAL; UNIVERSITY OF OSLO
    • RUNE – BLOMHOFF, DR. MED., Principal Investigator, University of Oslo

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