Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline

Study Overview
=================
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.

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.

Official Title
-----------------
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline

Conditions
-----------------
Age-related Memory Disorders, Mood Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 fatty acid
* Dietary Supplement: Blueberry powder
* Other: Placebo oil
* Other: Placebo powder


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 62 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 and Blueberry powder<br>This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months) | Dietary Supplement: Omega-3 fatty acid<br>* A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).<br>* Other names: OmegaRx capsules;Dietary Supplement: Blueberry powder<br>* Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.<br>|
| Experimental: Omega-3 and placebo powder<br>This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months) | Dietary Supplement: Omega-3 fatty acid<br>* A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).<br>* Other names: OmegaRx capsules;Other: Placebo powder<br>* Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.<br>|
| Experimental: Placebo oil and blueberry powder<br>This group will receive placebo oil and blueberry powder for 24 weeks (6 months). | Dietary Supplement: Blueberry powder<br>* Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.<br>Other: Placebo oil<br>* Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.<br>|
| Placebo Comparator: Placebo oil and placebo powder<br>This group will receive placebo oil and placebo powder for 24 weeks (6 months) | Other: Placebo oil<br>* Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.<br>Other: Placebo powder<br>* Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood Assessment | The following scale will be used to assess mood: Geriatric Depression Scale Geriatric Anxiety Inventory | 6 months | 
| Daily Functioning Assessment | The following scale will be used to measure daily functioning: - Older Americans Resources and Services Functional Assessment Questionnaire | 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 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Working memory, Long-term memory, Neurocognition, Dietary supplementation, dementia