Dietary Reduction of Advanced Glycation End Products to Prevent Cognitive Decline in Elderly Diabetics - a Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change from baseline in AGEs markers in serum (carboxymethyl lysine, CML and Methylglyoxal ,MG ) at 6 months
研究概览
简要总结
Basic science and observational human studies suggest that high conentrations of circulating Advanced Glycation End-products (AGEs) may promote cognitive decline in older adults. The purpose of this pilot study is to test the methodology and feasibility of a dietary intervention to lower AGEs in elderly diabetics in order to lay the foundations for a future fully powered randomized clinical trial (RCT).To this end, the present study is focused on recruitment strategies, adherence to an innovative intervention in older adults and study methods. An exploratory aim will be the effect of the intervention on cognition and cerebral blood flow in order to obtain necessary data to estimate effect-size for a future fully-powered RCT.
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
- Single (Outcomes Assessor)
盲法说明
The participants and study dietitian can not be blind to the assigned dietary intervention. However, the clinical testing and all data analysis are carried out blind to the intervention.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above the age 65
- •T2D diagnosis
- •no dementia (i.e MCI or cognitively normal )
- •Not receiving cholinesterase inhibitors
- •No other neurological (e.g. stroke, Parkinson's disease) or psychiatric conditions (e.g. schizophrenia, depression) that may affect cognition
- •Dietary AGE levels > 13kU
- •Not participating in another clinical trial
- •An informant that is willing to actively support the participant throughout the study
排除标准
- •Other major neuropsychiatric condition that might affect cognition
研究组 & 干预措施
Low AGEs diet
Participants randomized to this arm will receive active instruction on reducing dietary AGEs intake, in addition to standard of care dietary guidance for type 2 diabetes.
干预措施: Low AGEs diet (Behavioral)
Low AGEs diet
Participants randomized to this arm will receive active instruction on reducing dietary AGEs intake, in addition to standard of care dietary guidance for type 2 diabetes.
干预措施: Standard of care dietary guidance for Type 2 diabetes (Behavioral)
Standard of care dietary guidance
Participants randomized to this arm will only recieve standard of care dietary guidance for type 2 diabetes.
干预措施: Standard of care dietary guidance for Type 2 diabetes (Behavioral)
结局指标
主要结局
Change from baseline in AGEs markers in serum (carboxymethyl lysine, CML and Methylglyoxal ,MG ) at 6 months
时间窗: 6 months
Blood draws before and at the end of the intervention
次要结局
- recruiting rate assessment(2 years of total recruitment)
- retention rate to the diet(6 months)
研究者
Dr. Ithamar Ganmore
Principle investigator
Sheba Medical Center