Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
1 other identifier
interventional
94
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 5, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedMay 27, 2016
May 1, 2016
6 years
December 5, 2012
May 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (3)
Mood Assessment
6 months
Daily Functioning Assessment
6 months
Long-term memory function
6 months
Other Outcomes (1)
Ancillary Measures
6 months
Study Arms (4)
Omega 3 and Blueberry powder
EXPERIMENTALThis group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)
Omega-3 and placebo powder
EXPERIMENTALThis group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)
Placebo oil and blueberry powder
EXPERIMENTALThis group will receive placebo oil and blueberry powder for 24 weeks (6 months).
Placebo oil and placebo powder
PLACEBO COMPARATORThis group will receive placebo oil and placebo powder for 24 weeks (6 months)
Interventions
A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.
Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.
Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Related Publications (2)
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.
PMID: 29458842DERIVEDBoespflug 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.
PMID: 26812512DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Krikorian, PhD
University of Cincinnati
- PRINCIPAL INVESTIGATOR
Robert McNamara, PhD
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 5, 2012
First Posted
December 10, 2012
Study Start
January 1, 2010
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
May 27, 2016
Record last verified: 2016-05