Fatty Acid Modulation of Brain Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Working Memory Performance
研究概览
简要总结
In this crossover study, the investigtors will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period. The goal is to study how the fatty acid content of the diet affects brain functioning in healthy adults aged 65-75 years. One experimental diet will have a high palmitic acid (PA)/oleic acid (OA) ratio (HPA), typical of the North American diet. The other experimental diet will have a low PA/OA ratio (HOA), typical of the Mediterranean Diet. All allowed food and drink (except water) will be provided by the investigative team, and compliance will be enhanced by constant, intense dietary surveillance by a registered dietitian.
详细描述
This study will examine how manipulating dietary fatty acids affects brain functioning in older adults. Prior studies have shown that there are behavioral changes that can be made to improve cognition in adults on an acute time scale including improving sleep and physical activity. Based on preclinical data and prior studies in humans the investigators propose that brain functioning also can be acutely improved with a reduction in dietary saturated fat. This approach will first be used in cognitively normal older adults without dementia, but in the future it may be that improving baseline cognition is beneficial in patients with mild cognitive impairment and Alzheimer's disease even if the overall course of the patient's neurological condition is increasingly impaired cognitive function.
The investigators will manipulate the dietary ratios of palmitic acid (PA) and oleic acid (OA), which are the most prevalent saturated and monounsaturated fatty acids, respectively in the diet and body lipids. Using a crossover study of men and women, aged 65-75 years, the investigators will administer two experimental diets in a random order for one week and each experimental diet will be preceded by a one-week, low fat control diet for a four-week total study period. One experimental diet will have a high PA/OA ratio typical of the usual North American Diet and the other experimental diet will have a low PA/OA ratio typical of the Mediterranean Diet. The following primary outcomes will be assessed: working memory performance, activation of working memory networks using functional magnetic resonance imaging (fMRI) and functional connectivity.
The impact of this study is that these data may suggest one mechanism for acutely improving cognition in healthy older adults and potentially in those with cognitive impairment such as mild cognitive impairment and Alzheimer's disease. While changing dietary behavior long term requires additional investigation, there are potential immediate benefits to acute improvements in cognition on quality of life for older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Each of the two experimental diets will be masked and only the dietician and statistician will be unblinded. Subjects will be assigned to one of two diet orders and the masking will be matched across the sexes.
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women age range 65-75 years
- •Normal cognition (see Research Strategy for details on cognitive assessments)
- •"Healthy" (body mass index (BMI) of 20-40 kg/m2)
排除标准
- •Significant cognitive or behavioral impairment (see Research Strategy for testing and exclusions) or pharmacological treatment for this (e.g. antipsychotics, anxiolytics, and sedative medications).
- •Hormone replacement therapy, past 3 months.
- •Hyper-androgenic condition.
- •HbA1C≥7.5% and or Fasting plasma glucose concentration ≥130 mg/dL.
- •Type 2 Diabetes if receiving any other therapy than metformin.
- •Use of nicotine or ingestion of caffeine or alcohol during the study.
- •Habitual fat intake < 25% of kcal or strict vegetarian diet.
- •Sleep apnea requiring continuous positive airway pressure at night.
- •Lung, cardiac (heart failure or its treatment), liver disease, renal disease, cancer, and any other medical disorder known or thought to cause inflammation or abnormalities of cognition
- •Actively training for an athletic event or participating in competitive sports (such as league play or tournaments)
- •Intolerance or allergy to any of the food provided in the study.
研究组 & 干预措施
High Palmitic Acid Diet (HPA)
Participants will ingest the HPA diet for one week. The saturated fatty acid will be high in palmitic acid which is the most prevalent saturated fatty acid in the American diet. The HPA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids.
干预措施: High Palmitic Acid Diet (Dietary Supplement)
High Oleic Acid/Low Palmitic Acid Diet (HOA)
Participants will ingest the HOA diet for one week. The monounsaturated fatty acid will be high in oleic acid which is the most prevalent monounsaturated fatty acid in the Mediterranean diet. The HOA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids.
干预措施: High Oleic Acid Diet (Dietary Supplement)
结局指标
主要结局
Working Memory Performance
时间窗: after 7 days of each diet
Accuracy for performance on the Nback working memory test during fMRI
Working Memory Brain Activation
时间窗: after 7 days of each diet
Blood Oxygen Level Dependent (BOLD) activation during the Nback working memory test during fMRI
Working Memory Brain Functional Connectivity
时间窗: after 7 days of each diet
BOLD functional connectivity during resting state fMRI
次要结局
未报告次要终点
研究者
Julie Dumas
Professor
University of Vermont