NCT01746303

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 62 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Age-related Memory Disorders
• Mood Disorders

Interventions

Type	Name	Description
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).
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.
OTHER	Placebo powder	Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.

Timeline

• Start date: 2010-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-12-10
• Last updated: 2016-05-27

Locations

1 site across 1 country: United States