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Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline

This study is currently recruiting participants.
Verified December 2012 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Robert Krikorian, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01746303
First received: December 5, 2012
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Working Memory and Executive Ability function [ 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: December 2014
Estimated Primary Completion Date: July 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746303

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Robert Krikorian, PhD     513-558-4224     robert.krikorian@uc.edu    
Contact: Marcy Shidler, MA     513-558-2455     marcelle.shidler@uc.edu    
Principal Investigator: Robert Krikorian, PhD            
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Robert Krikorian, 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 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Working memory
Long-term memory
Neurocognition
Dietary supplementation

Additional relevant MeSH terms:
Memory Disorders
Cognition Disorders
Mood Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013