MemoryEarly Phase 1BLUEBERRYNCT00972972
Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters
A Early Phase 1 study testing bilberry (European blueberries) and red grape juice in people with Memory and Gene Expression, run by Ullevaal University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 67 to 77 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Memory, Gene Expression
- What is being tested?
- bilberry (European blueberries) and red grape juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2006to Dec 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 67 to 77 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- men
- age 67-77 years
- gradual subjective memory decline
- response to advertisement
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- bilberry (European blueberries) and red grape juice, placebo juice
- Keywords
- fruit polyphenols, phytochemicals, neurocognition, neuropsychology, psychopharmacology, gene expression, biochemistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilberry (European blueberries) and red grape juiceDietary supplement
Also called Bilberry, European blueberries, polyphenols
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 juiceDietary supplement
Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| dietary supplement | Active comparator | Extracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.) Receives: Dietary Supplement: bilberry (European blueberries) and red grape juice |
| placebo dietary supplement | Placebo comparator | Placebo juice extracts Receives: Dietary Supplement: placebo juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychological test scores and whole blood gene regulation
Measured: December 2006 - july 2007
whole blood gene regulation; parameters in blood
Measured: 2006 and 2007
neuropsychological test scores; whole blood gene regulation; parameters in blood
Measured: 2006 and 2007
Secondary outcomes (1)
gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood
Measured: 2007 and 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startDec 2006
- Primary completionJul 2007 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- KJELL - FLEKKOY, DR. PHILOS., Principal investigator, ULLEVAAL UNIVERSITY HOSPITAL; UNIVERSITY OF OSLORUNE - BLOMHOFF, DR. MED., Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972972
- Sponsor's protocol ID
- 699
- Acronym
- BLUEBERRY
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34802467
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters in Normal, Aged Men With Subjective Memory Decline
- ClinicalTrials.gov ID
- NCT00972972
- Acronym / sponsor ID
- BLUEBERRY / 699
- Conditions
- Memory, Gene Expression
- Keywords
- fruit polyphenols, phytochemicals, neurocognition, neuropsychology, psychopharmacology, gene expression, biochemistry
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Dec 2006
- Primary completion
- Jul 2007 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary supplement | Active comparator | Dietary Supplement: bilberry (European blueberries) and red grape juiceExtracts of bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.) |
| placebo dietary supplement | Placebo comparator | Dietary Supplement: placebo juicePlacebo juice extracts |
Who may qualify
- Ages
- 67 to 77 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- men
- age 67-77 years
- gradual subjective memory decline
- response to advertisement
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilberry (European blueberries) and red grape juiceAlso: Bilberry, European blueberries, polyphenolsIntervention juice: 50/50 combination of 300 ml bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.) per day for 9 weeks | Dietary supplement | dietary supplement |
| placebo juicePlacebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates | Dietary supplement | placebo dietary supplement |
Primary outcome
neuropsychological test scores and whole blood gene regulation
Time frame: December 2006 - july 2007
whole blood gene regulation; parameters in blood
Time frame: 2006 and 2007
neuropsychological test scores; whole blood gene regulation; parameters in blood
Time frame: 2006 and 2007
1 secondary outcome
gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood
Time frame: 2007 and 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Derived from this study: PubMed 34802467Bohn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KJELL - FLEKKOY, DR. PHILOS. principal investigator
ULLEVAAL UNIVERSITY HOSPITAL; UNIVERSITY OF OSLO
RUNE - BLOMHOFF, DR. MED. principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bilberry (European blueberries) and red grape juice in people with Memory and Gene Expression, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychological test scores and whole blood gene regulation (time frame: December 2006 - july 2007). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.