Aging, Cognitive Decline, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALLow AGEs diet
Oral and written instructions on how to reduce AGEs in diet, mainly by changing cooking methods in addition to standard of care dietary guidance for type 2 diabetes
BEHAVIORALStandard of care dietary guidance for Type 2 diabetes
Oral and written instructions for standard of care dietary guidance for type 2 diabetes
Sponsors
Hebrew University of Jerusalem
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
A randomized pilot trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Dementia * Stroke * Other major neuropsychiatric condition that might affect cognition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The influence of AGE reduction on cognition | 6 months | Changes in cognition using a Z score of global and domain specific (language, attention, memory ) cognition following 6 months of AGEs reduction compared to standard of care (this is an exploratory aim since this is a pilot study) |
| The influence of AGE reduction on cerebral blood flow-measured with arterial spin labeling MRI (ASL-MRI) | 6 months | changes in cerebral blood flow measured with ASL MRI following 6 months of AGEs reduction compared to standard of care ( this is an exploratory aim since this is a pilot study) |
| Change in microbial diversity and composition of fecal microbiome following AGE reduction in diet | 6 months | microbiota composition will be analyzed (eg. the amount and relative proportions of major bacterial genus and species Bifidobacterium, Bacteroides, Lactobaillus, Enterobacteria, Eubacteria,etc. using 16S rRNA profiling ) before and after intervention of AGEs reduction and changes will compared to standard of care arm. This is a descriptive exploratory outcome. |
Countries
Israel
Outcome results
None listed