Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline
- Conditions
- Subjective Cognitive Decline (SCD)
- Interventions
- Dietary Supplement: PolyamineDietary Supplement: Placebo
- Registration Number
- NCT03094546
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polyamine supplementation Polyamine Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract Placebo Placebo Intervention: Dietary Supplement Placebo: 750 mg cellulose
- Primary Outcome Measures
Name Time Method Change in Memory performance from neuropsychological test change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months) Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention
- Secondary Outcome Measures
Name Time Method Change in inflammation change from baseline after 12 month comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
Change in Brain imaging biomarkers change from baseline after 12 month Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging
Change in polyamine concentration change from baseline after 12 month comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
Change in Autophagy processes change from baseline after 12 month Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention
Change in Cognitive Function (from extended neuropsychological test battery) change from baseline after 12 month Comparing cognitive function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention
Trial Locations
- Locations (1)
Charité University Medicine Berlin, CCM, Department of Neurology,
🇩🇪Berlin, Germany