An interventional study of Omega-3 fatty acid and Blueberry powder in Age-related Memory Disorders and Mood Disorders, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 62 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-27.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Treatment
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.
260 studies on the registry are indexed under Memory Disorders; 60 are open to participants now.
This study's enrollment of 94 is above the median of 73 across 207 interventional studies indexed under Memory Disorders.
Browse Memory Disorders studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
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Exclusion Criteria:
This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)
Dietary Supplement: Omega-3 fatty acid · Dietary Supplement: Blueberry powder
This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)
Dietary Supplement: Omega-3 fatty acid · Other: Placebo powder
This group will receive placebo oil and blueberry powder for 24 weeks (6 months).
Dietary Supplement: Blueberry powder · Other: Placebo oil
This group will receive placebo oil and placebo powder for 24 weeks (6 months)
Other: Placebo oil · Other: Placebo powder
A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
Also known as: OmegaRx capsules
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.
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
Time frame: 6 months
Mood Assessment
The following scale will be used to assess mood: * Geriatric Depression Scale * Geriatric Anxiety Inventory
Time frame: 6 months
Daily Functioning Assessment
The following scale will be used to measure daily functioning: - Older Americans Resources and Services Functional Assessment Questionnaire
Time frame: 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
Time frame: 6 months
Ancillary Measures
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
Time frame: 6 months
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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