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

NCT ID: NCT00972972

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-12-31

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.

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

Conditions

Memory; Gene Expression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

dietary supplement

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

Group Type: ACTIVE_COMPARATOR

bilberry (European blueberries) and red grape juice

Intervention Type: DIETARY_SUPPLEMENT

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 dietary supplement

Placebo juice extracts

Group Type: PLACEBO_COMPARATOR

placebo juice

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

placebo juice

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Bilberry; European blueberries; polyphenols

Eligibility Criteria

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

• Minimum Eligible Age: 67 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ulleval University Hospital

Principal Investigators

KJELL - FLEKKOY, DR. PHILOS.

Role: PRINCIPAL_INVESTIGATOR

ULLEVAAL UNIVERSITY HOSPITAL; UNIVERSITY OF OSLO

RUNE - BLOMHOFF, DR. MED.

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

Ulleval University Hospital HF

Oslo, , Norway

Countries

Norway

References

Bohn SK, Myhrstad MCW, Thoresen M, Erlund I, Vasstrand AK, Marciuch A, Carlsen MH, Bastani NE, Engedal K, Flekkoy KM, Blomhoff R. Bilberry/red grape juice decreases plasma biomarkers of inflammation and tissue damage in aged men with subjective memory impairment -a randomized clinical trial. BMC Nutr. 2021 Nov 22;7(1):75. doi: 10.1186/s40795-021-00482-8.

Reference Type: DERIVED

PMID: 34802467 (View on PubMed)

Other Identifiers

699

Identifier Type: -

Identifier Source: org_study_id