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Completed

NCT Number: NCT02739971

Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

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.

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Key information

Conditions

Cognitive Decline Aging Cognition Disorders Cognitive Dysfunction Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joseph Sagol Neuroscience center, Sheba Medical Center

Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Low AGEs diet

Behavioral

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 diabetes

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Hebrew University of Jerusalem

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 15, 2016
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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