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

Sponsor

Ullevaal University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00972972

Collaborator

University of Oslo (Other)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Memory Gene Expression	Dietary Supplement: bilberry (European blueberries) and red grape juice Dietary Supplement: placebo juice	Early Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Dec 1, 2006

Anticipated Primary Completion Date :

Jul 1, 2007

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

neuropsychological test scores and whole blood gene regulation [December 2006 - july 2007]
whole blood gene regulation; parameters in blood [2006 and 2007]
neuropsychological test scores; whole blood gene regulation; parameters in blood [2006 and 2007]

Secondary Outcome Measures

gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood [2007 and 2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

67 Years to 77 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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