Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

Sheba Medical Center

Status: Completed

Conditions: Aging; Cognitive Decline; Type 2 Diabetes

Treatments: Behavioral: Standard of care dietary guidance for Type 2 diabetes; Behavioral: Low AGEs diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02739971

SHEBA-15-2206-IG-CTIL

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups, including a placebo group

Low AGEs diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of care dietary guidance for Type 2 diabetes

Behavioral: Low AGEs diet

Standard of care dietary guidance

Placebo Comparator group

Description:

Participants randomized to this arm will only recieve standard of care dietary guidance for type 2 diabetes.

Treatment:

Behavioral: Standard of care dietary guidance for Type 2 diabetes