Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline

Subjective Cognitive Decline (SCD) Clinical Trial

— SmartAge  

Official title:

Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094546
• Other study ID #: SmartAge
• Status: Completed
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: October 2020

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 and further characterization of individuals with subjective cognitive decline.

Description:

Memory abilities are known to decline during aging, a process that is accelerated in pathological conditions like mild cognitive impairment (MCI) and Alzheimer's disease (AD), all of which are a growing public-health concern with devastating social and economical 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 cognitive function and biomarkers of elderly individuals (60-90 years old) with subjective cognitive decline (SCD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

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

• 60-90 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

• Drug abuse or alcohol dependency

• Current polyamine substitution

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Subjective Cognitive Decline (SCD)

Intervention

Dietary Supplement:
• Polyamine
12 months of polyamine supplementation (6 capsules/day)
• Placebo
12 months of placebo intake (6 capsules/day)

Locations

Country	Name	City	State
Germany	Charité University Medicine Berlin, CCM, Department of Neurology,	Berlin

Sponsors (3)

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

Country where clinical trial is conducted

Germany, 

References & Publications (8)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Memory performance from neuropsychological test	Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention	change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months)
Secondary	Change in Cognitive Function (from extended neuropsychological test battery)	Comparing cognitive function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention	change from baseline after 12 month
Secondary	Change in polyamine concentration	comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention	change from baseline after 12 month
Secondary	Change in inflammation	comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention	change from baseline after 12 month
Secondary	Change in Brain imaging biomarkers	Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging	change from baseline after 12 month
Secondary	Change in Autophagy processes	Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention	change from baseline after 12 month
Secondary	Change in Autophagy processes	Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention	change from baseline after 12 month

External Links

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