Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Change in blood ketone levels induced by ketogenic diet
研究概览
简要总结
The purpose of the KDRAFT study is to assess the feasibility and preliminary cognitive efficacy of a ketogenic diet therapy in patients with Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's disease (CDR 0.5, 1, & 2)
- •Active study partner
- •BMI > 21
- •English speaking
排除标准
- •BMI < 21
- •Consume greater than 14 drinks of alcohol per week
- •Insulin Dependent Diabetes Mellitus
- •Diagnosis of active cancer
- •Myocardial infarction or symptoms of coronary artery disease (e.g. angina) in last year
研究组 & 干预措施
Ketogenic Diet Arm
All participants will be assigned to the 3-month ketogenic diet intervention. Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, <10% carbohydrate, and 20% protein). Participants will be provided medium chain triglyceride oil with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet.
干预措施: Ketogenic Diet (Behavioral)
结局指标
主要结局
Change in blood ketone levels induced by ketogenic diet
时间窗: Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).
Serum beta-hydroxybutyrate levels will be measured at five monthly study visits; baseline prior to diet initiation, three monthly collections during the ketogenic diet intervention, and after the 1-month washout return to a regular diet.
Proportion of days positive for urinary ketone production
时间窗: Daily for 90 days (the length of the diet intervention)
Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).
次要结局
- Dietary intake characterization prior to and after ketogenic diet initiation(Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3)
- Change in cognitive performance on the Mini-Mental State Exam (MMSE)(Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).)
- Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)(Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).)
研究者
Debra K. Sullivan, PhD, RD
Debra K Sullivan, PhD, RD, Chair and Endowed Professor of Clinical Nutrition
University of Kansas Medical Center