Age-related Memory DisordersNCT01746303
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
A study testing Omega-3 fatty acid and Blueberry powder in people with Age-related Memory Disorders and Mood Disorders, run by University of Cincinnati at 1 site in United States.
Trial summary
The aim of this study is to determine the efficacy of 6 months' dietary supplementation with omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older adults. Read more about this study
- Who is it for?
- Ages 62 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Memory Disorders, Mood Disorders
- What is being tested?
- Omega-3 fatty acid and Blueberry powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2016
- Phase
- Interventional
- 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 62 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women aged 62 to 80 years and older
- age-associated decline operationalized as Clinical Dementia Rating = 0, Auditory Verbal Learning Test cumulative acquisition score between 1.0 standard deviation below and 1.0 standard deviation above the age-corrected mean or Montreal Cognitive Assessment score greater than 25, and Geriatric Depression Scale score less than 16
- ability to comprehend and comply with the research protocol
- provision of written informed consent.
Who cannot join
- established dementia or neurological disorder including but not limited to probable Alzheimer's Disease, Parkinson's Disease, Frontotemporal dementia, multi-infarct dementia, and leukoencephalopathy
- current or past severe psychiatric disorder such as psychosis or major mood disorder requiring hospitalization and/or causing a change in level of occupational or social functioning
- current or past alcohol or drug abuse disorder causing physiological dependence or change in functional capability (nicotine dependence is permitted)
- diagnosis of diabetes or other metabolic disorder or kidney or liver disease
- use of medication that might affect outcome measures or interact with omega 3 fatty acid supplements such as benzodiazepines, aspirin, and serotonin reuptake inhibitors
- hematological coagulation disorder
- allergy to shellfish or seafood; 8) current supplementation with fish oil or consumption of fish more than once per week.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the efficacy of 6 months' dietary supplementation with omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older adults. The effects of each of these interventions alone will also be assessed in order to determine whether the combined treatment confers synergistic or additive benefit relative to the effect of each therapy.
Read the detailed description
After meeting inclusion criteria, one hundred-forty men and women, aged 62 to 80 years old, will be enrolled and randomly assigned to one of four groups: 1) omega-3 fatty acid and blueberry powder supplement, 2) omega-3 fatty acid and placebo powder, 3) placebo oil and blueberry powder supplement, or 4) placebo oil and placebo powder. They will participate in a 24-week intervention with major assessments including neuropsychological and functional evaluation at pre-treatment baseline and during the final week of the intervention. In addition, an interim evaluation of neurocognitive function will be conducted at 12 weeks. Subjects will be asked to maintain diet diaries for three periods during the study. Mood will be assessed as a potential covariate of the neurobehavioral outcome measures and data on red blood cell fatty acid content, metabolic parameters, inflammation, and anthropometric factors will be gathered to assess compliance and explore individual differences in response to the intervention and to evaluate potential mechanisms of action.
- Conditions
- Age-related Memory Disorders, Mood Disorders
- Being tested
- Omega-3 fatty acid, Blueberry powder, Placebo oil, Placebo powder
- Keywords
- Working memory, Long-term memory, Neurocognition, Dietary supplementation, dementia
- Medical subject headings
- Memory Disorders, Mood Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDietary supplement
Also called OmegaRx capsules
A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
Blueberry powderDietary supplement
Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.
Placebo oilOther
Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.
Placebo powderOther
Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 and Blueberry powder | Experimental | This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months) Receives: Dietary Supplement: Omega-3 fatty acid; Dietary Supplement: Blueberry powder |
| Omega-3 and placebo powder | Experimental | This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months) Receives: Dietary Supplement: Omega-3 fatty acid; Other: Placebo powder |
| Placebo oil and blueberry powder | Experimental | This group will receive placebo oil and blueberry powder for 24 weeks (6 months). Receives: Dietary Supplement: Blueberry powder; Other: Placebo oil |
| Placebo oil and placebo powder | Placebo comparator | This group will receive placebo oil and placebo powder for 24 weeks (6 months) Receives: Other: Placebo oil; Other: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory and Executive Ability
The following tests will be administered to measure working memory function:
- Porteus Maze Test
- Verbal Primary Memory with Interference Test
- Letter Number Sequencing Task
- Controlled Oral Word Production Task
Measured: 6 months
Secondary outcomes (3)
Mood Assessment
The following scale will be used to assess mood:
- Geriatric Depression Scale
- Geriatric Anxiety Inventory
Measured: 6 months
Daily Functioning Assessment
The following scale will be used to measure daily functioning:
- Older Americans Resources and Services Functional Assessment Questionnaire
Measured: 6 months
Long-term memory function
The following assessments will be conducted to measure Long-term memory function:
- California Verbal Learning Test, Second Edition
- Visual Nonverbal Recognition Memory Test
- Verbal Paired Associate Learning Task
- Spatial Paired Associate Learning Task
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age-related Memory DisordersStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Krikorian, University of Cincinnati
- Investigators
- Robert Krikorian, PhD, Principal investigator, University of CincinnatiRobert McNamara, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746303
- Sponsor's protocol ID
- 1R01AG034617-01
- Status last verified
- May 2016
- First submitted
- 5 Dec 2012
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McNamara RK, Kalt W, Shidler MD, McDonald J, Summer SS, Stein AL, Stover AN, Krikorian R. Cognitive response to fish oil, blueberry, and combined supplementation in older adults with subjective cognitive impairment. Neurobiol Aging. 2018 Apr;64:147-156. doi: 10.1016/j.neurobiolaging.2017.12.003. Epub 2017 Dec 12.
PubMed 29458842Boespflug EL, McNamara RK, Eliassen JC, Schidler MD, Krikorian R. Fish Oil Supplementation Increases Event-Related Posterior Cingulate Activation in Older Adults with Subjective Memory Impairment. J Nutr Health Aging. 2016 Feb;20(2):161-9. doi: 10.1007/s12603-015-0609-6.
PubMed 26812512
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
- ClinicalTrials.gov ID
- NCT01746303
- Acronym / sponsor ID
- 1R01AG034617-01
- Conditions
- Age-related Memory Disorders, Mood Disorders
- Keywords
- Working memory, Long-term memory, Neurocognition, Dietary supplementation, dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Dec 2012 (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 aim of this study is to determine the efficacy of 6 months' dietary supplementation with omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older adults. The effects of each of these interventions alone will also be assessed in order to determine whether the combined treatment confers synergistic or additive benefit relative to the effect of each therapy.
Detailed description
After meeting inclusion criteria, one hundred-forty men and women, aged 62 to 80 years old, will be enrolled and randomly assigned to one of four groups: 1) omega-3 fatty acid and blueberry powder supplement, 2) omega-3 fatty acid and placebo powder, 3) placebo oil and blueberry powder supplement, or 4) placebo oil and placebo powder. They will participate in a 24-week intervention with major assessments including neuropsychological and functional evaluation at pre-treatment baseline and during the final week of the intervention. In addition, an interim evaluation of neurocognitive function will be conducted at 12 weeks. Subjects will be asked to maintain diet diaries for three periods during the study. Mood will be assessed as a potential covariate of the neurobehavioral outcome measures and data on red blood cell fatty acid content, metabolic parameters, inflammation, and anthropometric factors will be gathered to assess compliance and explore individual differences in response to the intervention and to evaluate potential mechanisms of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Omega 3 and Blueberry powder | Experimental | Dietary Supplement: Omega-3 fatty acid, Dietary Supplement: Blueberry powderThis group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months) |
| Omega-3 and placebo powder | Experimental | Dietary Supplement: Omega-3 fatty acid, Other: Placebo powderThis group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months) |
| Placebo oil and blueberry powder | Experimental | Dietary Supplement: Blueberry powder, Other: Placebo oilThis group will receive placebo oil and blueberry powder for 24 weeks (6 months). |
| Placebo oil and placebo powder | Placebo comparator | Other: Placebo oil, Other: Placebo powderThis group will receive placebo oil and placebo powder for 24 weeks (6 months) |
Who may qualify
- Ages
- 62 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women aged 62 to 80 years and older
- age-associated decline operationalized as Clinical Dementia Rating = 0, Auditory Verbal Learning Test cumulative acquisition score between 1.0 standard deviation below and 1.0 standard deviation above the age-corrected mean or Montreal Cognitive Assessment score greater than 25, and Geriatric Depression Scale score less than 16
- ability to comprehend and comply with the research protocol
- provision of written informed consent.
Key exclusion criteria (7 listed)
- established dementia or neurological disorder including but not limited to probable Alzheimer's Disease, Parkinson's Disease, Frontotemporal dementia, multi-infarct dementia, and leukoencephalopathy
- current or past severe psychiatric disorder such as psychosis or major mood disorder requiring hospitalization and/or causing a change in level of occupational or social functioning
- current or past alcohol or drug abuse disorder causing physiological dependence or change in functional capability (nicotine dependence is permitted)
- diagnosis of diabetes or other metabolic disorder or kidney or liver disease
- use of medication that might affect outcome measures or interact with omega 3 fatty acid supplements such as benzodiazepines, aspirin, and serotonin reuptake inhibitors
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 |
|---|---|---|
| Omega-3 fatty acidAlso: OmegaRx capsulesA fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d). | Dietary supplement | Omega 3 and Blueberry powder, Omega-3 and placebo powder |
| Blueberry powderWhole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries. | Dietary supplement | Omega 3 and Blueberry powder, Placebo oil and blueberry powder |
| Placebo oilCorn oil capsules that are identical in size, shape, and color to omega-3 capsules. | Other | Placebo oil and blueberry powder, Placebo oil and placebo powder |
| Placebo powderPlacebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder. | Other | Omega-3 and placebo powder, Placebo oil and placebo powder |
Primary outcome
Working Memory and Executive Ability
Time frame: 6 months
The following tests will be administered to measure working memory function: * Porteus Maze Test * Verbal Primary Memory with Interference Test * Letter Number Sequencing Task * Controlled Oral Word Production Task
3 secondary outcomes
Mood Assessment
Time frame: 6 months
Daily Functioning Assessment
Time frame: 6 months
Long-term memory function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Derived from this study: PubMed 29458842McNamara RK, Kalt W, Shidler MD, McDonald J, Summer SS, Stein AL, Stover AN, Krikorian R. Cognitive response to fish oil, blueberry, and combined supplementation in older adults with subjective cognitive impairment. Neurobiol Aging. 2018 Apr;64:147-156. doi: 10.1016/j.neurobiolaging.2017.12.003. Epub 2017 Dec 12.
- Derived from this study: PubMed 26812512Boespflug EL, McNamara RK, Eliassen JC, Schidler MD, Krikorian R. Fish Oil Supplementation Increases Event-Related Posterior Cingulate Activation in Older Adults with Subjective Memory Impairment. J Nutr Health Aging. 2016 Feb;20(2):161-9. doi: 10.1007/s12603-015-0609-6.
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.
Robert Krikorian, PhD principal investigator
University of Cincinnati
Robert McNamara, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid and Blueberry powder in people with Age-related Memory Disorders and Mood Disorders, run by University of Cincinnati at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 27 May 2016. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Working Memory and Executive Ability (time frame: 6 months). 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 NCT01746303, which also lists 2 linked publications.
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 27 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.