dc.contributor.author
Wirth, Miranka
dc.contributor.author
Schwarz, Claudia
dc.contributor.author
Benson, Gloria
dc.contributor.author
Horn, Nora
dc.contributor.author
Buchert, Ralph
dc.contributor.author
Lange, Catharina
dc.contributor.author
Köbe, Theresa
dc.contributor.author
Hetzer, Stefan
dc.contributor.author
Maglione, Marta
dc.contributor.author
Michael, Eva
dc.contributor.author
Märschenz, Stefanie
dc.contributor.author
Mai, Knut
dc.contributor.author
Kopp, Ute
dc.contributor.author
Schmitz, Dietmar
dc.contributor.author
Grittner, Ulrike
dc.contributor.author
Sigrist, Stephan J.
dc.contributor.author
Stekovic, Slaven
dc.contributor.author
Madeo, Frank
dc.contributor.author
Flöel, Agnes
dc.date.accessioned
2019-06-27T14:54:54Z
dc.date.available
2019-06-27T14:54:54Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/24948
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-2708
dc.description.abstract
Background: Given the global increase in the aging population and age-related diseases, the promotion of healthy aging is one of the most crucial public health issues. This trial aims to contribute to the establishment of effective approaches to promote cognitive and brain health in older individuals with subjective cognitive decline (SCD). Presence of SCD is known to increase the risk of objective cognitive decline and progression to dementia due to Alzheimer’s disease. Therefore, it is our primary goal to determine whether spermidine supplementation has a positive impact on memory performance in this at-risk group, as compared with placebo. The secondary goal is to examine the effects of spermidine intake on other neuropsychological, behavioral, and physiological parameters.
Methods: The SmartAge trial is a monocentric, randomized, double-blind, placebo-controlled phase IIb trial. The study will investigate 12 months of intervention with spermidine-based nutritional supplementation (target intervention) compared with 12months of placebo intake (control intervention). We plan to recruit 100 cognitively normal older individuals with SCD from memory clinics, neurologists and general practitioners in private practice, and the general population. Participants will be allocated to one of the two study arms using blockwise randomization stratified by age and sex with a 1:1 allocation ratio. The primary outcome is the change in memory performance between baseline and post-intervention visits (12 months after baseline). Secondary outcomes include the change in memory performance from baseline to follow-up assessment (18months after baseline), as well as changes in neurocognitive, behavioral, and physiological parameters (including blood and neuroimaging biomarkers), assessed at baseline and post-intervention.
Discussion: The SmartAge trial aims to provide evidence of the impact of spermidine supplementation on memory performance in older individuals with SCD. In addition, we will identify possible neurophysiological mechanisms of action underlying the anticipated cognitive benefits. Overall, this trial will contribute to the establishment of nutrition intervention in the prevention of Alzheimer’s disease.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
Dietary supplementation
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)—study protocol for a randomized controlled trial
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.articlenumber
36
dcterms.bibliographicCitation.doi
10.1186/s13195-019-0484-1
dcterms.bibliographicCitation.journaltitle
Alzheimer’s Research & Therapy
dcterms.bibliographicCitation.originalpublishername
BMC
dcterms.bibliographicCitation.volume
11
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
31039826
dcterms.isPartOf.eissn
1758-9193