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Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

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ClinicalTrials.gov Identifier: NCT02739971
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by (Responsible Party):
Dr. Ithamar Ganmore, Sheba Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Aging Type 2 Diabetes Behavioral: Low AGEs diet Behavioral: Standard of care dietary guidance for Type 2 diabetes Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized pilot trial
Masking: Single (Outcomes Assessor)
Masking Description: The participants and study dietitian can not be blind to the assigned dietary intervention. However, the clinical testing and all data analysis are carried out blind to the intervention.
Primary Purpose: Prevention
Official Title: Dietary Reduction of Advanced Glycation End Products to Prevent Cognitive Decline in Elderly Diabetics - a Randomized Pilot Trial
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. recruiting rate assessment [ Time Frame: 2 years of total recruitment ]
    calculate the eligible subjects from those attended screening visit

  2. retention rate to the diet [ Time Frame: 6 months ]
    to report the retention rate


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739971


Locations
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Israel
Joseph Sagol Neuroscience center, Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Hebrew University of Jerusalem
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Ithamar Ganmore, Principle investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02739971    
Other Study ID Numbers: SHEBA-15-2206-IG-CTIL
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders