Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega 3 and Blueberry powder | Experimental | This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months) |
|
| Omega-3 and placebo powder | Experimental | This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months) |
|
| Placebo oil and blueberry powder | Experimental | This group will receive placebo oil and blueberry powder for 24 weeks (6 months). |
|
| Placebo oil and placebo powder | Placebo Comparator | This group will receive placebo oil and placebo powder for 24 weeks (6 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid | Dietary Supplement | A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Working Memory and Executive Ability | The following tests will be administered to measure working memory function:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mood Assessment | The following scale will be used to assess mood:
| 6 months |
| Daily Functioning Assessment | The following scale will be used to measure daily functioning: - Older Americans Resources and Services Functional Assessment Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Ancillary Measures | The following measures will be collected:
| 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Krikorian, PhD | University of Cincinnati | Principal Investigator |
| Robert McNamara, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29458842 | Derived | 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. | |
| 26812512 | Derived | Boespflug 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| D019964 | Mood Disorders |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Blueberry powder | Dietary Supplement | Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries. |
|
| Placebo oil | Other | Corn oil capsules that are identical in size, shape, and color to omega-3 capsules. |
|
| Placebo powder | Other | Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder. |
|
| 6 months |
| Long-term memory function | The following assessments will be conducted to measure Long-term memory function:
| 6 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |