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Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
This study has been completed.
Sponsor:
University of Cincinnati
Information provided by (Responsible Party):
Robert Krikorian, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01746303
First received: December 5, 2012
Last updated: May 25, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Age-related Memory Disorders Mood Disorders | Dietary Supplement: Omega-3 fatty acid Dietary Supplement: Blueberry powder Other: Placebo oil Other: Placebo powder |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline |
Resource links provided by NLM:
Further study details as provided by Robert Krikorian, University of Cincinnati:
Primary Outcome Measures:
- Working Memory and Executive Ability [ Time Frame: 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:
- Mood Assessment [ Time Frame: 6 months ]
The following scale will be used to assess mood:
- Geriatric Depression Scale
- Geriatric Anxiety Inventory
- Daily Functioning Assessment [ Time Frame: 6 months ]
The following scale will be used to measure daily functioning:
- Older Americans Resources and Services Functional Assessment Questionnaire
- Long-term memory function [ Time Frame: 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
Other Outcome Measures:
- Ancillary Measures [ Time Frame: 6 months ]
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
| Enrollment: | 94 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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 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.
|
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.
Eligibility| Ages Eligible for Study: | 62 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01746303
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746303
Locations
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45219 | |
Sponsors and Collaborators
University of Cincinnati
Investigators
| Principal Investigator: | Robert Krikorian, PhD | University of Cincinnati |
| Principal Investigator: | Robert McNamara, PhD | University of Cincinnati |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Robert Krikorian, Professor, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01746303 History of Changes |
| Other Study ID Numbers: |
1R01AG034617-01 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 5, 2012 |
| Last Updated: | May 25, 2016 |
Keywords provided by Robert Krikorian, University of Cincinnati:
|
Working memory Long-term memory Neurocognition Dietary supplementation dementia |
Additional relevant MeSH terms:
|
Disease Mood Disorders Memory Disorders Pathologic Processes Mental Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 19, 2017