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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Ullevaal University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00972972
First received: September 3, 2009
Last updated: September 11, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Memory
Gene Expression
Dietary Supplement: bilberry (European blueberries) and red grape juice
Dietary Supplement: placebo juice
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters in Normal, Aged Men With Subjective Memory Decline

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • neuropsychological test scores and whole blood gene regulation [ Time Frame: December 2006 - july 2007 ] [ Designated as safety issue: No ]
  • whole blood gene regulation; parameters in blood [ Time Frame: 2006 and 2007 ] [ Designated as safety issue: No ]
  • neuropsychological test scores; whole blood gene regulation; parameters in blood [ Time Frame: 2006 and 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood [ Time Frame: 2007 and 2009 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dietary supplement
Extracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.)
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
Other Names:
  • Bilberry
  • European blueberries
  • polyphenols
Placebo Comparator: placebo dietary supplement
Placebo juice extracts
Dietary Supplement: placebo juice
Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates

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

  Eligibility

Ages Eligible for Study:   67 Years to 77 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972972

Locations
Norway
Ulleval University Hospital HF
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Investigators
Principal Investigator: KJELL - FLEKKOY, DR. PHILOS. ULLEVAAL UNIVERSITY HOSPITAL; UNIVERSITY OF OSLO
Principal Investigator: RUNE - BLOMHOFF, DR. MED. University of Oslo
  More Information

No publications provided

Responsible Party: Ulleval University Hospital
ClinicalTrials.gov Identifier: NCT00972972     History of Changes
Other Study ID Numbers: 699
Study First Received: September 3, 2009
Last Updated: September 11, 2009
Health Authority: Norway: Ethics Committee

Keywords provided by Ullevaal University Hospital:
fruit polyphenols
phytochemicals
neurocognition
neuropsychology
psychopharmacology
gene expression
biochemistry

ClinicalTrials.gov processed this record on November 27, 2014