At a glance

ClinicalIndex Comparison Record

N/ACompleted· 75 enrolled

Drug / intervention

Low AGEs diet +1 morebehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02739971

NCT02739971N/ACompleted

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

Sheba Medical Center·interventional·Posted Apr 15, 2016·Updated Mar 23, 2021

In Brief

A clinical study evaluating Low AGEs diet and Standard of care dietary guidance for Type 2 diabetes for Cognitive Decline and 2 related conditions. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCognitive Decline, Aging, Type 2 Diabetes

CountriesIsrael

CollaboratorsHebrew University of Jerusalem

Timeline

N/ACompletedFinished

2017201820192020202120222023202420252026

First PostedApr 2016

Enrollment StartJun 2016

Primary CompletionJun 2019

Study CompletionJun 2020

TodayJul 2026

First PostedApr 15, 2016

Enrollment StartJun 1, 2016

Primary CompletionJun 1, 2019

Study CompletionJun 1, 2020

TodayJul 2, 2026

Enrollment to primary: 3 yearsPosted 10.2 years ago

Interventions

Low AGEs dietbehavioral

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

Standard of care dietary guidance for Type 2 diabetesbehavioral

Oral and written instructions for standard of care dietary guidance for type 2 diabetes