Back to resultsOmega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
Primary Purpose
Age-related Memory Disorders, Mood Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acid
Blueberry powder
Placebo oil
Placebo powder
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Memory Disorders focused on measuring Working memory, Long-term memory, Neurocognition, Dietary supplementation, dementia
Eligibility Criteria
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.
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Omega 3 and Blueberry powder
Omega-3 and placebo powder
Placebo oil and blueberry powder
Placebo oil and placebo powder
Arm Description
This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)
This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)
This group will receive placebo oil and blueberry powder for 24 weeks (6 months).
This group will receive placebo oil and placebo powder for 24 weeks (6 months)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mood Assessment
The following scale will be used to assess mood:
Geriatric Depression Scale
Geriatric Anxiety Inventory
Daily Functioning Assessment
The following scale will be used to measure daily functioning:
- Older Americans Resources and Services Functional Assessment Questionnaire
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
Full Information
NCT ID
NCT01746303
First Posted
December 5, 2012
Last Updated
May 25, 2016
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01746303
Brief Title
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
Official Title
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Memory Disorders, Mood Disorders
Keywords
Working memory, Long-term memory, Neurocognition, Dietary supplementation, dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega 3 and Blueberry powder
Arm Type
Experimental
Arm Description
This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)
Arm Title
Omega-3 and placebo powder
Arm Type
Experimental
Arm Description
This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)
Arm Title
Placebo oil and blueberry powder
Arm Type
Experimental
Arm Description
This group will receive placebo oil and blueberry powder for 24 weeks (6 months).
Arm Title
Placebo oil and placebo powder
Arm Type
Placebo Comparator
Arm Description
This group will receive placebo oil and placebo powder for 24 weeks (6 months)
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid
Other Intervention Name(s)
OmegaRx capsules
Intervention Description
A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry powder
Intervention Description
Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.
Intervention Type
Other
Intervention Name(s)
Placebo oil
Intervention Description
Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.
Intervention Type
Other
Intervention Name(s)
Placebo powder
Intervention Description
Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.
Primary Outcome Measure Information:
Title
Working Memory and Executive Ability
Description
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
Secondary Outcome Measure Information:
Title
Mood Assessment
Description
The following scale will be used to assess mood:
Geriatric Depression Scale
Geriatric Anxiety Inventory
Time Frame
6 months
Title
Daily Functioning Assessment
Description
The following scale will be used to measure daily functioning:
- Older Americans Resources and Services Functional Assessment Questionnaire
Time Frame
6 months
Title
Long-term memory function
Description
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
Other Pre-specified Outcome Measures:
Title
Ancillary Measures
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
62 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Krikorian, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert McNamara, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29458842
Citation
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.
Results Reference
derived
PubMed Identifier
26812512
Citation
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.
Results Reference
derived
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Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
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