Clinical trial NCT01746303: 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
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Memory Disorders
Mood Disorders
Keywords: Working memory
Long-term memory
Neurocognition
Dietary supplementation
dementia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 94
Sex: ALL
Minimum age (years): 62
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Working Memory and Executive Ability
timeFrame: 6 months
Secondary outcomes:
measure: Mood Assessment
timeFrame: 6 months
measure: Daily Functioning Assessment
timeFrame: 6 months
measure: Long-term memory function
timeFrame: 6 months
Other outcomes:
measure: Ancillary Measures
timeFrame: 6 months
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert Krikorian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Robert McNamara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.