Polyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline

Subjective Cognitive Decline Clinical Trial

— preSmartAge  

Official title:

Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function in Healthy Older Adults With Subjective Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755246
• Other study ID #: preSmartAge
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: April 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.

Description:

Memory abilities are known to decline during aging, a process that is accelerated in pathological conditions like subjective, mild cognitive impairment (MCI) and Alzheimer's disease (AD), all of which are a growing public-health concern with devastating effects. Polyamines supplementation and corresponding up-regulation of autophagy (i.e., cellular protein degradation pathways) may be a key target of intervention against age-related memory decline. The study will investigate whether a polyamine-enriched dietary supplementation (through capsule intake) could provide positive effects on the cognitive function of elderly individuals (60-80 years old) with subjective cognitive decline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cognitive healthy subjects with subjective memory decline and self-reported concerns

• 60-80 years old

• No manifest dementia (DSM-IV criteria)

• No limitations in activities of daily living

• Capacity for consent

Exclusion Criteria:

• Gluten, histamine or wheat seedling intolerance

• 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 or ASS therapy

• Drug abuse or alcohol dependency

• Current polyamine substitution

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Subjective Cognitive Decline

Intervention

Dietary Supplement:
• Polyamine supplementation
3 months of polyamine supplementation (3 capsules/day)
• Placebo supplementation
3 months of placebo intake (3 capsules/day)

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany, Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria

Country where clinical trial is conducted

Germany, 

References & Publications (10)

Eisenberg T, Knauer H, Schauer A, Büttner 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, Fröhlich 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. — View Citation

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. — View Citation

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. Epub 2013 Feb 7. — View Citation

Minois N, Carmona-Gutierrez D, Madeo F. Polyamines in aging and disease. Aging (Albany NY). 2011 Aug;3(8):716-32. Review. — View Citation

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. — View Citation

Schwarz C, Stekovic S, Wirth M, Benson G, Royer P, Sigrist SJ, Pieber T, Dammbrueck C, Magnes C, Eisenberg T, Pendl T, Bohlken J, Köbe T, Madeo F, Flöel A. Safety and tolerability of spermidine supplementation in mice and older adults with subjective cogn — View Citation

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. — View Citation

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. — View Citation

Tiboldi A, Lentini A, Provenzano B, Tabolacci C, Höger 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. — View Citation

Wirth M, Benson G, Schwarz C, Köbe T, Grittner U, Schmitz D, Sigrist SJ, Bohlken J, Stekovic S, Madeo F, Flöel A. The effect of spermidine on memory performance in older adults at risk for dementia: A randomized controlled trial. Cortex. 2018 Dec;109:181- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Function (from neuropsychological test battery)	Comparing changes in cognitive function in subjects with polyamine intake and placebo treatment (pre vs. post intervention)	Prior to intervention (baseline) and after 3 months of intervention
Secondary	Laboratory parameters	comparing different markers derived from blood plasma like polyamine concentration (spermine, spermidine) and markers of inflammation pre vs. post intervention	Prior to intervention (baseline) and after 3 months of intervention
Secondary	Vascular parameters	Comparing intima-media-thickness pre vs. post intervention	Prior to intervention (baseline) and after 3 months of intervention

External Links

•   working group is related to healthy aging, cognitive impairments in aging and neurological rehabilitation after stroke