MedTrace Logo

Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

NCT02739971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-03-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hebrew University of Jerusalem

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Michal Schnaider Beeri, PhD · The Joseph Sagol Neuroscience Center

  • Aron M Troen, DPhil · Hebrew University of Jerusalem

  • Ramit Ravona Springer, MD · The Joseph Sagol Neuroscience Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-06-30
Completion
2020-06-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02739971 on ClinicalTrials.gov