Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

Study Overview
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Brief Summary
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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.

Official Title
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Dietary Reduction of Advanced Glycation End Products to Prevent Cognitive Decline in Elderly Diabetics - a Randomized Pilot Trial

Conditions
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Cognitive Decline, Aging, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Low AGEs diet
* Behavioral: Standard of care dietary guidance for Type 2 diabetes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized pilot trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low AGEs diet<br>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. | Behavioral: Low AGEs diet<br>* 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<br>Behavioral: Standard of care dietary guidance for Type 2 diabetes<br>* Oral and written instructions for standard of care dietary guidance for type 2 diabetes<br>|
| Placebo Comparator: Standard of care dietary guidance<br>Participants randomized to this arm will only recieve standard of care dietary guidance for type 2 diabetes. | Behavioral: Standard of care dietary guidance for Type 2 diabetes<br>* Oral and written instructions for standard of care dietary guidance for type 2 diabetes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in AGEs markers in serum (carboxymethyl lysine, CML and Methylglyoxal ,MG ) at 6 months | Blood draws before and at the end of the intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruiting rate assessment | calculate the eligible subjects from those attended screening visit | 2 years of total recruitment | 
| retention rate to the diet | to report the retention rate | 6 months |