Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics
NCT ID: NCT02739971
Last Updated: 2021-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2016-06-30
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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
Standard of care dietary guidance for Type 2 diabetes
Oral and written instructions for standard of care dietary guidance for type 2 diabetes
Standard of care dietary guidance
Participants randomized to this arm will only recieve standard of care dietary guidance for type 2 diabetes.
Standard of care dietary guidance for Type 2 diabetes
Oral and written instructions for standard of care dietary guidance for type 2 diabetes
Interventions
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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
Standard of care dietary guidance for Type 2 diabetes
Oral and written instructions for standard of care dietary guidance for type 2 diabetes
Eligibility Criteria
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Exclusion Criteria
* Stroke
* Other major neuropsychiatric condition that might affect cognition
65 Years
ALL
No
Sponsors
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Hebrew University of Jerusalem
OTHER
Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Ithamar Ganmore
Principle investigator
Principal Investigators
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Michal Schnaider Beeri, PhD
Role: PRINCIPAL_INVESTIGATOR
The Joseph Sagol Neuroscience Center
Aron M Troen, DPhil
Role: PRINCIPAL_INVESTIGATOR
Hebrew University of Jerusalem
Ramit Ravona Springer, MD
Role: STUDY_DIRECTOR
The Joseph Sagol Neuroscience Center
Locations
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Joseph Sagol Neuroscience center, Sheba Medical Center
Ramat Gan, , Israel
Countries
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References
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Uribarri J, Woodruff S, Goodman S, Cai W, Chen X, Pyzik R, Yong A, Striker GE, Vlassara H. Advanced glycation end products in foods and a practical guide to their reduction in the diet. J Am Diet Assoc. 2010 Jun;110(6):911-16.e12. doi: 10.1016/j.jada.2010.03.018.
Cai W, Uribarri J, Zhu L, Chen X, Swamy S, Zhao Z, Grosjean F, Simonaro C, Kuchel GA, Schnaider-Beeri M, Woodward M, Striker GE, Vlassara H. Oral glycotoxins are a modifiable cause of dementia and the metabolic syndrome in mice and humans. Proc Natl Acad Sci U S A. 2014 Apr 1;111(13):4940-5. doi: 10.1073/pnas.1316013111. Epub 2014 Feb 24.
Lubitz I, Ricny J, Atrakchi-Baranes D, Shemesh C, Kravitz E, Liraz-Zaltsman S, Maksin-Matveev A, Cooper I, Leibowitz A, Uribarri J, Schmeidler J, Cai W, Kristofikova Z, Ripova D, LeRoith D, Schnaider-Beeri M. High dietary advanced glycation end products are associated with poorer spatial learning and accelerated Abeta deposition in an Alzheimer mouse model. Aging Cell. 2016 Apr;15(2):309-16. doi: 10.1111/acel.12436. Epub 2016 Jan 19.
Uribarri J, Cai W, Ramdas M, Goodman S, Pyzik R, Chen X, Zhu L, Striker GE, Vlassara H. Restriction of advanced glycation end products improves insulin resistance in human type 2 diabetes: potential role of AGER1 and SIRT1. Diabetes Care. 2011 Jul;34(7):1610-6. doi: 10.2337/dc11-0091.
Ravona-Springer R, Luo X, Schmeidler J, Wysocki M, Lesser G, Rapp M, Dahlman K, Grossman H, Haroutunian V, Schnaider Beeri M. Diabetes is associated with increased rate of cognitive decline in questionably demented elderly. Dement Geriatr Cogn Disord. 2010;29(1):68-74. doi: 10.1159/000265552. Epub 2010 Jan 30.
Luchsinger JA, Reitz C, Patel B, Tang MX, Manly JJ, Mayeux R. Relation of diabetes to mild cognitive impairment. Arch Neurol. 2007 Apr;64(4):570-5. doi: 10.1001/archneur.64.4.570.
Beeri MS, Moshier E, Schmeidler J, Godbold J, Uribarri J, Reddy S, Sano M, Grossman HT, Cai W, Vlassara H, Silverman JM. Serum concentration of an inflammatory glycotoxin, methylglyoxal, is associated with increased cognitive decline in elderly individuals. Mech Ageing Dev. 2011 Nov-Dec;132(11-12):583-7. doi: 10.1016/j.mad.2011.10.007. Epub 2011 Nov 3.
West RK, Moshier E, Lubitz I, Schmeidler J, Godbold J, Cai W, Uribarri J, Vlassara H, Silverman JM, Beeri MS. Dietary advanced glycation end products are associated with decline in memory in young elderly. Mech Ageing Dev. 2014 Sep;140:10-2. doi: 10.1016/j.mad.2014.07.001. Epub 2014 Jul 15.
Lotan R, Ganmore I, Livny A, Shelly S, Zacharia M, Uribarri J, Beisswenger P, Cai W, Schnaider Beeri M, Troen AM. Design and Feasibility of a Randomized Controlled Pilot Trial to Reduce Exposure and Cognitive Risk Associated With Advanced Glycation End Products in Older Adults With Type 2 Diabetes. Front Nutr. 2021 Feb 15;8:614149. doi: 10.3389/fnut.2021.614149. eCollection 2021.
Lotan R, Ganmore I, Shelly S, Zacharia M, Uribarri J, Beisswenger P, Cai W, Troen AM, Schnaider Beeri M. Long Term Dietary Restriction of Advanced Glycation End-Products (AGEs) in Older Adults with Type 2 Diabetes Is Feasible and Efficacious-Results from a Pilot RCT. Nutrients. 2020 Oct 15;12(10):3143. doi: 10.3390/nu12103143.
Other Identifiers
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SHEBA-15-2206-IG-CTIL
Identifier Type: -
Identifier Source: org_study_id
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