Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

Not Applicable

Completed

• Conditions: Aging; Cognitive Decline; Type 2 Diabetes
• Interventions: Behavioral: Standard of care dietary guidance for Type 2 diabetes; Behavioral: Low AGEs diet

• 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

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Study Start: 2016-06
• Primary Completion: 2019-06
• Study Completion: 2020-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

• Dementia
• Stroke
• Other major neuropsychiatric condition that might affect cognition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care dietary guidance	Standard of care dietary guidance for Type 2 diabetes	Participants randomized to this arm will only recieve standard of care dietary guidance for type 2 diabetes.
Low AGEs diet	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.
Low AGEs diet	Standard of care dietary guidance for Type 2 diabetes	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.

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