Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline

Resource links provided by NLM:

MedlinePlus related topics: Memory Mood Disorders

Drug Information available for: Omega-3 Fatty Acids Vaccinium corymbosum

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Working Memory and Executive Ability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The following scale will be used to assess mood:
- Geriatric Depression Scale
- Geriatric Anxiety Inventory
Daily Functioning Assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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


Estimated Enrollment:	140
Study Start Date:	January 2010
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2015 (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
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


Responsible Party:	Robert Krikorian, Professor, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT01746303 History of Changes
Other Study ID Numbers:	1R01AG034617-01
Study First Received:	December 5, 2012
Last Updated:	December 22, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:


Working memory Long-term memory Neurocognition Dietary supplementation dementia

Additional relevant MeSH terms:


Disease Memory Disorders Mood Disorders Mental Disorders Nervous System Diseases	Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Signs and Symptoms

ClinicalTrials.gov processed this record on February 25, 2015