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

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

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.

Study Overview

• Status: Unknown
• Conditions: Memory; Gene Expression
• Intervention / Treatment: Dietary supplement: bilberry (European blueberries) and red grape juice; Dietary supplement: placebo juice

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Ullevål University Hospital HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 67 years to 77 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: polyphenols; Bilberry; European blueberries
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood	2007 and 2009

Collaborators and Investigators

• Sponsor: Ullevaal University Hospital
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Anticipated): July 1, 2007
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: September 3, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 11, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: neuropsychology; gene expression; phytochemicals; biochemistry; neurocognition; psychopharmacology; fruit polyphenols
• Other Study ID Numbers: 699 (Other Identifier: Shands UF Clinical Research Center)