Clinical trial NCT00972972: Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters
Official title: Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters in Normal, Aged Men With Subjective Memory Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Memory
Gene Expression
Keywords: fruit polyphenols
phytochemicals
neurocognition
neuropsychology
psychopharmacology
gene expression
biochemistry
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2009-09-09
Enrollment: 61
Sex: MALE
Minimum age (years): 67
Maximum age (years): 77
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Eligibility 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

Primary outcomes:
measure: neuropsychological test scores and whole blood gene regulation
timeFrame: December 2006 - july 2007
measure: whole blood gene regulation; parameters in blood
timeFrame: 2006 and 2007
measure: neuropsychological test scores; whole blood gene regulation; parameters in blood
timeFrame: 2006 and 2007
Secondary outcomes:
measure: gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood
timeFrame: 2007 and 2009
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital HF
Study officials:
affiliation: ULLEVAAL UNIVERSITY HOSPITAL; UNIVERSITY OF OSLO
name: KJELL - FLEKKOY, DR. PHILOS.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: RUNE - BLOMHOFF, DR. MED.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bohn SK, Myhrstad MCW, Thoresen M, Erlund I, Vasstrand AK, Marciuch A, Carlsen MH, Bastani NE, Engedal K, Flekkoy KM, Blomhoff R. Bilberry/red grape juice decreases plasma biomarkers of inflammation and tissue damage in aged men with subjective memory impairment -a randomized clinical trial. BMC Nutr. 2021 Nov 22;7(1):75. doi: 10.1186/s40795-021-00482-8.