Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study: Dietary Fat Quality and Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
研究概览
简要总结
The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.
详细描述
Study objective including
- To measure the impact of dietary fats on postprandial cognitive function in adults who report subjective cognitive complaints.
- To assess the effect of dietary fat consumption on the gut-brain axis in relationship to cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective cognitive impairment
- •BMI ≥30 kg/m2
- •HbA1C <6.5%
排除标准
- •Diagnosis og cognitive impairment or dementia
- •Montreal Cognitive Assessment (MoCA) score of <26
- •Current or previous diagnosis of Diabetes or use of diabetes medications
- •Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
- •Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) where consumption of the study foods would be contraindication or where the disease or disorder could negatively affect nutrient absorption and/or would prevent participants from tolerating the study foods
- •Hyperthyroidism diagnosis
- •Food Allergy or intolerances
- •Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
- •Use of some oil supplements in the past 4 weeks prior to enrolling
- •Pregnancy and lactation
- •Inability to access veins for venipuncture
- •Antibiotic use in the past month
- •Psychostimulant or nootropic medication use
- •Current use of supplements or medications for weight loss or following a weight loss program
- •Severe or uncontrolled autoimmune diseases
- •Current or previous diagnosis of severe kidney failure, liver cirrhosis and some pulmonary diseases
- •Heart disease events (including stroke or heart attack) within last 3 months prior to enrollment
- •Alcohol or drug abuse
研究组 & 干预措施
Walnuts
consumption of walnuts every day
干预措施: Walnuts (Other)
White chocolate-style bar
consumption of a white chocolate-style bar every day
干预措施: Simply White Diary-free chocolate bar (Other)
结局指标
主要结局
Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
时间窗: Week 0 and Week 5
To determine the impact of consuming the study dietary fats as part of a high fat meal on postprandial cognitive function
次要结局
- Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)(Week 0, Week 1, Week 5 and Week 6)
- Changes in fecal Microbiota diversity(Week 0, Week 1, Week 5 and Week 6)
研究者
Martha Belury
Professor and Chair, Food Science and Technology
Ohio State University