University of Cincinnati
Cincinnati, Ohio, 45219, United States
NCT Number: NCT01746303
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.
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Notify Me62 year–80 year
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45219, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
Other names: 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.
Time frame: 6 months
The following tests will be administered to measure working memory function:
Time frame: 6 months
The following scale will be used to assess mood:
Time frame: 6 months
The following scale will be used to measure daily functioning:
Time frame: 6 months
The following assessments will be conducted to measure Long-term memory function:
Time frame: 6 months
The following measures will be collected:
University of Cincinnati
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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