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

Not Applicable

Completed

• Conditions: Age-related Memory Disorders; Mood Disorders
• Interventions: Dietary Supplement: Omega-3 fatty acid; Other: Placebo oil; Dietary Supplement: Blueberry powder; Other: Placebo powder

• Registration Number: NCT01746303
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega 3 and Blueberry powder	Blueberry powder	This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)
Omega-3 and placebo powder	Omega-3 fatty acid	This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)
Omega-3 and placebo powder	Placebo powder	This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)
Placebo oil and placebo powder	Placebo oil	This group will receive placebo oil and placebo powder for 24 weeks (6 months)
Omega 3 and Blueberry powder	Omega-3 fatty acid	This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)
Placebo oil and placebo powder	Placebo powder	This group will receive placebo oil and placebo powder for 24 weeks (6 months)
Placebo oil and blueberry powder	Blueberry powder	This group will receive placebo oil and blueberry powder for 24 weeks (6 months).
Placebo oil and blueberry powder	Placebo oil	This group will receive placebo oil and blueberry powder for 24 weeks (6 months).

Primary Outcome Measures

Name	Time	Method
Working Memory and Executive Ability	6 months	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

Secondary Outcome Measures

Name	Time	Method
Mood Assessment	6 months	The following scale will be used to assess mood: * Geriatric Depression Scale; * Geriatric Anxiety Inventory
Long-term memory function	6 months	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
Daily Functioning Assessment	6 months	The following scale will be used to measure daily functioning: - Older Americans Resources and Services Functional Assessment Questionnaire

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States