Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
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ClinicalTrials.gov Identifier: NCT01746303 |
Recruitment Status :
Completed
First Posted : December 10, 2012
Last Update Posted : May 27, 2016
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Condition or disease | Intervention/treatment | Phase |
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Age-related Memory Disorders Mood Disorders | Dietary Supplement: Omega-3 fatty acid Dietary Supplement: Blueberry powder Other: Placebo oil Other: Placebo powder | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | January 2016 |
Arm | Intervention/treatment |
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Experimental: Omega 3 and Blueberry powder
This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)
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Dietary Supplement: Omega-3 fatty acid
A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
Other Name: OmegaRx capsules Dietary Supplement: Blueberry powder Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries. |
Experimental: Omega-3 and placebo powder
This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)
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Dietary Supplement: Omega-3 fatty acid
A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
Other Name: OmegaRx capsules Other: Placebo powder Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder. |
Experimental: Placebo oil and blueberry powder
This group will receive placebo oil and blueberry powder for 24 weeks (6 months).
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Dietary Supplement: Blueberry powder
Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries. Other: Placebo oil Corn oil capsules that are identical in size, shape, and color to omega-3 capsules. |
Placebo Comparator: Placebo oil and placebo powder
This group will receive placebo oil and placebo powder for 24 weeks (6 months)
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Other: Placebo oil
Corn oil capsules that are identical in size, shape, and color to omega-3 capsules. Other: Placebo powder Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder. |
- 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
- Mood Assessment [ Time Frame: 6 months ]
The following scale will be used to assess mood:
- Geriatric Depression Scale
- Geriatric Anxiety Inventory
- Daily Functioning Assessment [ Time Frame: 6 months ]
The following scale will be used to measure daily functioning:
- Older Americans Resources and Services Functional Assessment Questionnaire
- Long-term memory function [ Time Frame: 6 months ]
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
- Ancillary Measures [ Time Frame: 6 months ]
The following measures will be collected:
- Red blood cell fatty acid composition
- Inflammatory and metabolic parameters
- Waist Circumference, Hip Circumference, Height, Body Weight, Blood pressure, Heart rate
- Urinary anthocyanin studies
- Diet Diaries

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Ages Eligible for Study: | 62 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746303
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45219 |
Principal Investigator: | Robert Krikorian, PhD | University of Cincinnati | |
Principal Investigator: | Robert McNamara, PhD | University of Cincinnati |
Responsible Party: | Robert Krikorian, Professor, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT01746303 |
Other Study ID Numbers: |
1R01AG034617-01 ( U.S. NIH Grant/Contract ) |
First Posted: | December 10, 2012 Key Record Dates |
Last Update Posted: | May 27, 2016 |
Last Verified: | May 2016 |
Working memory Long-term memory Neurocognition Dietary supplementation dementia |
Memory Disorders Disease Cognitive Dysfunction Mood Disorders Pathologic Processes Cognition Disorders |
Neurocognitive Disorders Mental Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |