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

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.

Study Overview

• Status: Completed
• Conditions: Mood Disorders; Age-related Memory Disorders
• Intervention / Treatment: Dietary supplement: Omega-3 fatty acid; Dietary supplement: Blueberry powder; Other: Placebo powder; Other: Placebo oil

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 62 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Omega 3 and Blueberry powder; This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)	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).; Other Names: OmegaRx capsules; Dietary supplement: Blueberry powder; Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.
EXPERIMENTAL: Omega-3 and placebo powder; This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)	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).; Other Names: OmegaRx capsules; Other: Placebo powder; Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.
EXPERIMENTAL: Placebo oil and blueberry powder; This group will receive placebo oil and blueberry powder for 24 weeks (6 months).	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.
PLACEBO_COMPARATOR: Placebo oil and placebo powder; This group will receive placebo oil and placebo powder for 24 weeks (6 months)	Other: Placebo powder; Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.; Other: Placebo oil; Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: University of Cincinnati

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (ESTIMATE): December 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: dementia; Working memory; Dietary supplementation; Neurocognition; Long-term memory
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Disease; Cognitive Dysfunction; Mood Disorders; Memory Disorders
• Other Study ID Numbers: 1R01AG034617-01 (NIH)