Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
Overall Status:
Recruiting
Brief Description:
This study aims to determine the efficacy of 6 months' dietary supplementation with omega-3 fatty acids and freeze-dried blueberry powder in improving cognition in older adults. Each type of supplement will be tested alone and with the other to evaluate whether combined treatment confers any benefit.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
62 Years | 80 Years | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- Clinical Dementia Rating of 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
- Geriatric Depression Scale score of less than 16
- Ability to understand and follow the research protocol
Exclusion Criteria:
- Established dementia or neurological disorder including but not limited to probable Alzheimer's disease, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, or 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)
- Diabetes or other metabolic disorder, kidney disease, or liver disease
- Use of medication that might affect outcome measures or interact with omega-3 fatty acid supplements, for example, benzodiazepines, aspirin, and serotonin reuptake inhibitors
- Hematological coagulation disorder
- Allergy to shellfish or seafood
- Current supplementation with fish oil or consumption of fish more than once per week
Detailed Description:
Participants will be randomly assigned to one of four groups to test the impact of omega-3 fatty acids (2.4 grams/day as a capsule) and/or freeze-dried blueberry powder on older adults' cognition. One group will take both dietary supplements, another will take omega-3 fatty acids and a placebo powder, a third will take placebo omega-3 fatty acids and a blueberry powder supplement, and the last will take placebos for both supplements.
Neuropsychological and functional tests will be performed before and at the end of the 24-week intervention. In addition, an interim evaluation of neurocognitive function will be conducted at 12 weeks. Participants will maintain diet diaries for three periods during the study. Mood, red blood cell fatty-acid content, metabolic parameters, and inflammation will also be measured.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 39.1269228, -84.514354 | University of Cincinnati | Cincinnati | Ohio | 45219 | Recruiting |
Lead Sponsor:
| Agency |
|---|
University of Cincinnati |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Robert Krikorian, PhD | Principal Investigator | University of Cincinnati |
Study Contact:
| Name | Phone | |
|---|---|---|
Robert Krikorian, PhD | 513-558-4224 |
Locations
ClinicalTrials.gov ID
NCT01746303 (follow link to view full record on ct.gov in new window)
Official Title:
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
Study Start Date:
January 2010
Study End Date:
December 2014
Enrollment:
140
