Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics
- Conditions
- AgingCognitive DeclineType 2 Diabetes
- Registration Number
- NCT02739971
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Not provided
- Dementia
- Stroke
- Other major neuropsychiatric condition that might affect cognition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in AGEs markers in serum (carboxymethyl lysine, CML and Methylglyoxal ,MG ) at 6 months 6 months Blood draws before and at the end of the intervention
- Secondary Outcome Measures
Name Time Method recruiting rate assessment 2 years of total recruitment calculate the eligible subjects from those attended screening visit
retention rate to the diet 6 months to report the retention rate
Trial Locations
- Locations (1)
Joseph Sagol Neuroscience center, Sheba Medical Center
🇮🇱Ramat Gan, Israel
Joseph Sagol Neuroscience center, Sheba Medical Center🇮🇱Ramat Gan, Israel