Subjective Cognitive Decline
Conditions
Keywords
subjective cognitive decline, dementia, lifestyle, polyamine, memory, elderly, prevention, treatment, dietary supplement, Polyamine-enriched diet
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.
Interventions
DIETARY_SUPPLEMENTPolyamine supplementation
3 months of polyamine supplementation (3 capsules/day)
DIETARY_SUPPLEMENTPlacebo supplementation
3 months of placebo intake (3 capsules/day)
Sponsors
Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany
Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function (from neuropsychological test battery) | Prior to intervention (baseline) and after 3 months of intervention | Comparing changes in cognitive function in subjects with polyamine intake and placebo treatment (pre vs. post intervention) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory parameters | Prior to intervention (baseline) and after 3 months of intervention | comparing different markers derived from blood plasma like polyamine concentration (spermine, spermidine) and markers of inflammation pre vs. post intervention |
| Vascular parameters | Prior to intervention (baseline) and after 3 months of intervention | Comparing intima-media-thickness pre vs. post intervention |
Countries
Germany
Outcome results
None listed