Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline
NCT ID: NCT03094546
Last Updated: 2021-04-26
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
PHASE2
100 participants
INTERVENTIONAL
2017-01-31
2020-10-31
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
TREATMENT
TRIPLE
Study Groups
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Polyamine supplementation
Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract
Polyamine
12 months of polyamine supplementation (6 capsules/day)
Placebo
Intervention: Dietary Supplement Placebo: 750 mg cellulose
Placebo
12 months of placebo intake (6 capsules/day)
Interventions
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Polyamine
12 months of polyamine supplementation (6 capsules/day)
Placebo
12 months of placebo intake (6 capsules/day)
Eligibility Criteria
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Inclusion Criteria
* 60-90 years old
* No manifest dementia (DSM-IV criteria)
* No limitations in activities of daily living
* Capacity for consent
Exclusion Criteria
* Severe neurological, internal or psychological diseases
* Advanced heart or respiratory diseases, severe arteriosclerosis, untreated thyroid disease or diabetes
* Malignant tumors, current or past history
* Brain tumors, stroke
* Disorders that impair attention
* Dementia
* Coagulation disorder, Marcumar
* Drug abuse or alcohol dependency
* Current polyamine substitution
60 Years
90 Years
ALL
Yes
Sponsors
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Freie Universität, Institute of Biology/Genetic, Berlin, Germany
UNKNOWN
Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria
UNKNOWN
Charite University, Berlin, Germany
OTHER
Responsible Party
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Claudia Schwarz
Postdoctoral Researcher
Principal Investigators
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Agnes Floeel, Prof
Role: PRINCIPAL_INVESTIGATOR
Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin
Dietmar Schmitz, Prof
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité University Medicine Berlin, CCM, Department of Neurology,
Berlin, , Germany
Countries
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References
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Eisenberg T, Knauer H, Schauer A, Buttner S, Ruckenstuhl C, Carmona-Gutierrez D, Ring J, Schroeder S, Magnes C, Antonacci L, Fussi H, Deszcz L, Hartl R, Schraml E, Criollo A, Megalou E, Weiskopf D, Laun P, Heeren G, Breitenbach M, Grubeck-Loebenstein B, Herker E, Fahrenkrog B, Frohlich KU, Sinner F, Tavernarakis N, Minois N, Kroemer G, Madeo F. Induction of autophagy by spermidine promotes longevity. Nat Cell Biol. 2009 Nov;11(11):1305-14. doi: 10.1038/ncb1975. Epub 2009 Oct 4.
Gupta VK, Scheunemann L, Eisenberg T, Mertel S, Bhukel A, Koemans TS, Kramer JM, Liu KS, Schroeder S, Stunnenberg HG, Sinner F, Magnes C, Pieber TR, Dipt S, Fiala A, Schenck A, Schwaerzel M, Madeo F, Sigrist SJ. Restoring polyamines protects from age-induced memory impairment in an autophagy-dependent manner. Nat Neurosci. 2013 Oct;16(10):1453-60. doi: 10.1038/nn.3512. Epub 2013 Sep 1.
Ibe S, Kumada K, Yoshida K, Otobe K. Natto (fermented soybean) extract extends the adult lifespan of Caenorhabditis elegans. Biosci Biotechnol Biochem. 2013;77(2):392-4. doi: 10.1271/bbb.120726. Epub 2013 Feb 7.
Minois N, Carmona-Gutierrez D, Madeo F. Polyamines in aging and disease. Aging (Albany NY). 2011 Aug;3(8):716-32. doi: 10.18632/aging.100361.
Schaeffer V, Lavenir I, Ozcelik S, Tolnay M, Winkler DT, Goedert M. Stimulation of autophagy reduces neurodegeneration in a mouse model of human tauopathy. Brain. 2012 Jul;135(Pt 7):2169-77. doi: 10.1093/brain/aws143. Epub 2012 Jun 10.
Soda K, Dobashi Y, Kano Y, Tsujinaka S, Konishi F. Polyamine-rich food decreases age-associated pathology and mortality in aged mice. Exp Gerontol. 2009 Nov;44(11):727-32. doi: 10.1016/j.exger.2009.08.013. Epub 2009 Sep 6.
Soda K, Kano Y, Sakuragi M, Takao K, Lefor A, Konishi F. Long-term oral polyamine intake increases blood polyamine concentrations. J Nutr Sci Vitaminol (Tokyo). 2009 Aug;55(4):361-6. doi: 10.3177/jnsv.55.361.
Tiboldi A, Lentini A, Provenzano B, Tabolacci C, Hoger H, Beninati S, Lubec G. Hippocampal polyamine levels and transglutaminase activity are paralleling spatial memory retrieval in the C57BL/6J mouse. Hippocampus. 2012 May;22(5):1068-74. doi: 10.1002/hipo.22016. Epub 2012 Mar 30.
Schwarz C, Benson GS, Horn N, Wurdack K, Grittner U, Schilling R, Marschenz S, Kobe T, Hofer SJ, Magnes C, Stekovic S, Eisenberg T, Sigrist SJ, Schmitz D, Wirth M, Madeo F, Floel A. Effects of Spermidine Supplementation on Cognition and Biomarkers in Older Adults With Subjective Cognitive Decline: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2213875. doi: 10.1001/jamanetworkopen.2022.13875.
Wirth M, Schwarz C, Benson G, Horn N, Buchert R, Lange C, Kobe T, Hetzer S, Maglione M, Michael E, Marschenz S, Mai K, Kopp U, Schmitz D, Grittner U, Sigrist SJ, Stekovic S, Madeo F, Floel A. Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)-study protocol for a randomized controlled trial. Alzheimers Res Ther. 2019 May 1;11(1):36. doi: 10.1186/s13195-019-0484-1.
Related Links
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working group is related to healthy aging, cognitive impairments in aging and neurological rehabilitation after stroke
Other Identifiers
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SmartAge
Identifier Type: -
Identifier Source: org_study_id
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