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

Memory Clinical Trial

— BLUEBERRY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00972972
• Other study ID #: 699
• Status: Active, not recruiting
• Phase: Phase 0
• First received: September 3, 2009
• Last updated: September 11, 2009
• Start date: December 2006
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: December 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 67 Years to 77 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gene Expression
• Memory

Intervention

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
• placebo juice
Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates

Locations

Country	Name	City	State
Norway	Ulleval University Hospital HF	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropsychological test scores and whole blood gene regulation		December 2006 - july 2007	No
Primary	whole blood gene regulation; parameters in blood		2006 and 2007	No
Primary	neuropsychological test scores; whole blood gene regulation; parameters in blood		2006 and 2007	No
Secondary	gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood		2007 and 2009	No