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

Ullevaal University Hospital

Status and phase: Unknown; Early Phase 1

Conditions: Gene Expression; Memory

Treatments: Dietary Supplement: bilberry (European blueberries) and red grape juice; Dietary Supplement: placebo juice

Study type: Interventional

Funder types: Other

Identifiers

NCT00972972

699

Details and patient eligibility

About

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.

Full 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

Enrollment: 61 patients

Sex: Male

Ages: 67 to 77 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups, including a placebo group

dietary supplement

Active Comparator group

Description:

Extracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.)

Treatment:

Dietary Supplement: bilberry (European blueberries) and red grape juice

placebo dietary supplement

Placebo Comparator group

Description:

Placebo juice extracts

Treatment:

Dietary Supplement: placebo juice