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

NCT ID: NCT01746303

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Age-related Memory Disorders; Mood Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Omega 3 and Blueberry powder

This group will receive omega-3 fatty acid and blueberry powder supplement for 24 weeks (6 months)

Group Type: EXPERIMENTAL

Omega-3 fatty acid

Intervention Type: DIETARY_SUPPLEMENT

A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).

Blueberry powder

Intervention Type: DIETARY_SUPPLEMENT

Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.

Omega-3 and placebo powder

This group will receive omega-3 fatty acid and placebo powder for 24 weeks (6 months)

Group Type: EXPERIMENTAL

Omega-3 fatty acid

Intervention Type: DIETARY_SUPPLEMENT

A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).

Placebo powder

Intervention Type: OTHER

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

Placebo oil and blueberry powder

This group will receive placebo oil and blueberry powder for 24 weeks (6 months).

Group Type: EXPERIMENTAL

Blueberry powder

Intervention Type: DIETARY_SUPPLEMENT

Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.

Placebo oil

Intervention Type: OTHER

Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.

Placebo oil and placebo powder

This group will receive placebo oil and placebo powder for 24 weeks (6 months)

Group Type: PLACEBO_COMPARATOR

Placebo oil

Intervention Type: OTHER

Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.

Placebo powder

Intervention Type: OTHER

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

Interventions

Omega-3 fatty acid

A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).

Intervention Type: DIETARY_SUPPLEMENT

Blueberry powder

Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.

Intervention Type: DIETARY_SUPPLEMENT

Placebo oil

Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.

Intervention Type: OTHER

Placebo powder

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

Intervention Type: OTHER

Other Intervention Names

OmegaRx capsules

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.

• Minimum Eligible Age: 62 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Robert Krikorian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Krikorian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Robert McNamara, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29458842 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26812512 (View on PubMed)

Other Identifiers

1R01AG034617-01

Identifier Type: NIH

Identifier Source: org_study_id

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