NCT00972972

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2006

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

September 3, 2009

Last Update Submit

September 11, 2009

Conditions

MemoryGene Expression

Keywords

fruit polyphenolsphytochemicalsneurocognitionneuropsychologypsychopharmacologygene expressionbiochemistry

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood

    2007 and 2009

Study Arms (2)

dietary supplement

ACTIVE COMPARATOR

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

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

placebo dietary supplement

PLACEBO COMPARATOR

Placebo juice extracts

Dietary Supplement: placebo juice

Interventions

bilberry (European blueberries) and red grape juiceDIETARY_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

Also known as: Bilberry, European blueberries, polyphenols
dietary supplement
placebo juiceDIETARY_SUPPLEMENT

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

placebo dietary supplement

Eligibility Criteria

Age67 Years - 77 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • men
  • age 67-77 years
  • gradual subjective memory decline
  • response to advertisement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital HF

Oslo, 0407, Norway

Location

Related Publications (1)

  • 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.

    PMID: 34802467DERIVED

MeSH Terms

Interventions

Vaccinium myrtillus extractPolyphenols

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • KJELL - FLEKKOY, DR. PHILOS.

    ULLEVAAL UNIVERSITY HOSPITAL; UNIVERSITY OF OSLO

    PRINCIPAL INVESTIGATOR

  • RUNE - BLOMHOFF, DR. MED.

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 9, 2009

Study Start

December 1, 2006

Primary Completion

July 1, 2007

Study Completion

December 1, 2009

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

NO(1)