Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline

NCT03094546 | Completed Phase 2 DMC

• 1 other identifier: SmartAge
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subjective Cognitive Decline (SCD)

Keywords

subjective cognitive decline; Alzheimer's disease, dementia; dietary supplement; polyamine; prevention; treatment; lifestyle; memory; autophagy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Cognitive Function (from extended neuropsychological test battery)

  change from baseline after 12 month

• Change in polyamine concentration

  change from baseline after 12 month

• Change in inflammation

  change from baseline after 12 month

• Change in Brain imaging biomarkers

  change from baseline after 12 month

• Change in Autophagy processes

  change from baseline after 12 month

Study Arms (2)

Polyamine supplementation

EXPERIMENTAL

Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract

Dietary Supplement: Polyamine

Placebo

PLACEBO COMPARATOR

Intervention: Dietary Supplement Placebo: 750 mg cellulose

Dietary Supplement: Placebo

Interventions

Polyamine DIETARY_SUPPLEMENT

12 months of polyamine supplementation (6 capsules/day)

Polyamine supplementation

Placebo DIETARY_SUPPLEMENT

12 months of placebo intake (6 capsules/day)

Placebo

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitive healthy individuals with subjective memory decline and self-reported concerns
• years old
• No manifest dementia (DSM-IV criteria)
• No limitations in activities of daily living
• Capacity for consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Freie Universität, Institute of Biology/Genetic, Berlin, Germany: collaborator
• Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria: collaborator

Study Sites (1)

Charité University Medicine Berlin, CCM, Department of Neurology,

Berlin, 10117, Germany

Location

Related Publications (10)

• 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.

  PMID: 19801973 BACKGROUND

• 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.

  PMID: 23995066 BACKGROUND

• 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.

  PMID: 23391920 BACKGROUND

• 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.

  PMID: 21869457 BACKGROUND

• 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.

  PMID: 22689910 BACKGROUND

• 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.

  PMID: 19735716 BACKGROUND

• 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.

  PMID: 19763038 BACKGROUND

• 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.

  PMID: 22467251 BACKGROUND

• 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.

  PMID: 35616942 DERIVED

• 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.

  PMID: 31039826 DERIVED

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Polyamines

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals

Study Officials

• Agnes Floeel, Prof

  Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin

  PRINCIPAL INVESTIGATOR

• Dietmar Schmitz, Prof

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 29, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

DE (1)