Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

March 18, 2021 updated by: Dr. Ithamar Ganmore, Sheba Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Joseph Sagol Neuroscience center, Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Low 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
Behavioral: Standard of care dietary guidance for Type 2 diabetes
Oral and written instructions for standard of care dietary guidance for type 2 diabetes
Placebo Comparator: Standard of care dietary guidance
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
Oral and written instructions for standard of care dietary guidance for type 2 diabetes

What is the study measuring?

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
Time Frame: 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
Time Frame: 2 years of total recruitment
calculate the eligible subjects from those attended screening visit
2 years of total recruitment
retention rate to the diet
Time Frame: 6 months
to report the retention rate
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence of AGE reduction on cognition
Time Frame: 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)
6 months
The influence of AGE reduction on cerebral blood flow-measured with arterial spin labeling MRI (ASL-MRI)
Time Frame: 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)
6 months
Change in microbial diversity and composition of fecal microbiome following AGE reduction in diet
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Hebrew University of Jerusalem

Investigators

  • Principal Investigator: Michal Schnaider Beeri, PhD, The Joseph Sagol Neuroscience Center
  • Principal Investigator: Aron M Troen, DPhil, Hebrew University of Jerusalem
  • Study Director: Ramit Ravona Springer, MD, The Joseph Sagol Neuroscience Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-15-2206-IG-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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