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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00972972
Other study ID # 699
Secondary ID
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


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
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