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

Mood Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746303
• Other study ID #: 1R01AG034617-01
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: May 25, 2016
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 62 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Memory Disorders
• Disease
• Memory Disorders
• Mood Disorders

Intervention

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).
• 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 powder
Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ancillary Measures	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	6 months	No
Primary	Working Memory and Executive Ability	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	6 months	No
Secondary	Mood Assessment	The following scale will be used to assess mood: Geriatric Depression Scale; Geriatric Anxiety Inventory	6 months	No
Secondary	Daily Functioning Assessment	The following scale will be used to measure daily functioning: - Older Americans Resources and Services Functional Assessment Questionnaire	6 months	No
Secondary	Long-term memory function	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	6 months	No