Back to resultsPolyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline (preSmartAge)
Primary Purpose
Subjective Cognitive Decline
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Polyamine supplementation
Placebo supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Subjective Cognitive Decline focused on measuring subjective cognitive decline, dementia, lifestyle, polyamine, memory, elderly, prevention, treatment, dietary supplement, Polyamine-enriched diet
Eligibility Criteria
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
Sites / Locations
- Charité Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Polyamine supplementation
Placebo
Arm Description
750 mg polyamine-rich plant extract per day
750 mg potato starch per day
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Laboratory parameters
comparing different markers derived from blood plasma like polyamine concentration (spermine, spermidine) and markers of inflammation pre vs. post intervention
Vascular parameters
Comparing intima-media-thickness pre vs. post intervention
Full Information
NCT ID
NCT02755246
First Posted
April 5, 2016
Last Updated
April 22, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany, Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria
1. Study Identification
Unique Protocol Identification Number
NCT02755246
Brief Title
Polyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline
Acronym
preSmartAge
Official Title
Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function in Healthy Older Adults With Subjective Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany, Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria
4. Oversight
5. Study Description
Brief Summary
The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline
Keywords
subjective cognitive decline, dementia, lifestyle, polyamine, memory, elderly, prevention, treatment, dietary supplement, Polyamine-enriched diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyamine supplementation
Arm Type
Experimental
Arm Description
750 mg polyamine-rich plant extract per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
750 mg potato starch per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyamine supplementation
Intervention Description
3 months of polyamine supplementation (3 capsules/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplementation
Intervention Description
3 months of placebo intake (3 capsules/day)
Primary Outcome Measure Information:
Title
Change in Cognitive Function (from neuropsychological test battery)
Description
Comparing changes in cognitive function in subjects with polyamine intake and placebo treatment (pre vs. post intervention)
Time Frame
Prior to intervention (baseline) and after 3 months of intervention
Secondary Outcome Measure Information:
Title
Laboratory parameters
Description
comparing different markers derived from blood plasma like polyamine concentration (spermine, spermidine) and markers of inflammation pre vs. post intervention
Time Frame
Prior to intervention (baseline) and after 3 months of intervention
Title
Vascular parameters
Description
Comparing intima-media-thickness pre vs. post intervention
Time Frame
Prior to intervention (baseline) and after 3 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, Prof. Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19801973
Citation
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.
Results Reference
background
PubMed Identifier
23995066
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.
Results Reference
background
PubMed Identifier
23391920
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. doi: 10.1271/bbb.120726. Epub 2013 Feb 7.
Results Reference
background
PubMed Identifier
21869457
Citation
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.
Results Reference
background
PubMed Identifier
22689910
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.
Results Reference
background
PubMed Identifier
19735716
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.
Results Reference
background
PubMed Identifier
19763038
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. doi: 10.3177/jnsv.55.361.
Results Reference
background
PubMed Identifier
22467251
Citation
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.
Results Reference
background
PubMed Identifier
30388439
Citation
Wirth M, Benson G, Schwarz C, Kobe T, Grittner U, Schmitz D, Sigrist SJ, Bohlken J, Stekovic S, Madeo F, Floel A. The effect of spermidine on memory performance in older adults at risk for dementia: A randomized controlled trial. Cortex. 2018 Dec;109:181-188. doi: 10.1016/j.cortex.2018.09.014. Epub 2018 Oct 4.
Results Reference
result
PubMed Identifier
29315079
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, Kobe T, Madeo F, Floel A. Safety and tolerability of spermidine supplementation in mice and older adults with subjective cognitive decline. Aging (Albany NY). 2018 Jan 8;10(1):19-33. doi: 10.18632/aging.101354.
Results Reference
result
Links:
URL
https://neurocure.de/klinisches-zentrum/forschung-am-ncrc/ncrc-investigator/ehemahlige-ncrc-arbeitsgruppen.html
Description
working group is related to healthy aging, cognitive impairments in aging and neurological rehabilitation after stroke
Learn more about this trial
Polyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline
We'll reach out to this number within 24 hrs