NCT06898424已完成不适用
Effects of Concurrent Plant-Based Ketogenic Diet and Intermittent Fasting (Ketoflex 12/3) on the Clinical Progression of Early-to-Mid Stage Alzheimer's Dementia
Prof. Lutfu Hanoglu, MD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function as Measured by the MMSE Score
研究概览
简要总结
This study investigates the effects of the Ketoflex 12/3 diet on the clinical progression of early-to-mid stage Alzheimer's disease. The study evaluates cognitive function, metabolic changes, and overall health outcomes in participants following the Ketoflex 12/3 dietary protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50-85 years
- •Clinical Dementia Rating (CDR) score of 1 or2
- •Diagnosis of Alzheimer's disease (AD) according to NIA-AA criteria
排除标准
- •Alcohol and/or substance dependence
- •Diagnosis of chronic renal failure
- •Diagnosis of another neuropsychiatric disorder
- •Presence of amalgam dental fillings and/or failure to have them removed following the SMART protocol
结局指标
主要结局
Change in Cognitive Function as Measured by the MMSE Score
时间窗: Baseline and 6 months
Mini-Mental State Examination (MMSE) will be used to assess cognitive function before and after the intervention. The Mini-Mental State Examination (MMSE) is used to assess cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
次要结局
未报告次要终点
研究者
Prof. Lutfu Hanoglu, MD
Prof. MD
Istanbul Medipol University Hospital
研究点 (1)
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