Overview

This trial is active, not recruiting.

Conditions memory, gene expression
Treatments bilberry (european blueberries) and red grape juice, placebo juice
Phase phase 0
Sponsor Ullevaal University Hospital
Collaborator University of Oslo
Start date December 2006
End date July 2007
Trial size 61 participants
Trial identifier NCT00972972, 699

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
Extracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.)
bilberry (european blueberries) and red grape juice Bilberry
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
(Placebo Comparator)
Placebo juice extracts
placebo juice
Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates

Primary Outcomes

Measure
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 Outcomes

Measure
gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood
time frame: 2007 and 2009

Eligibility Criteria

Male participants from 67 years up to 77 years old.

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

Additional Information

Official title Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters in Normal, Aged Men With Subjective Memory Decline
Principal investigator KJELL - FLEKKOY, DR. PHILOS.
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Ullevaal University Hospital.