Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Working Memory and Executive Ability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 62 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Working Memory and Executive Ability
时间窗: 6 months
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
次要结局
- Mood Assessment(6 months)
- Long-term memory function(6 months)
- Daily Functioning Assessment(6 months)
研究者
Robert Krikorian
Professor
University of Cincinnati