Clinical trial NCT02755246: Polyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline
Official title: Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function in Healthy Older Adults With Subjective Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subjective Cognitive Decline
Keywords: subjective cognitive decline
dementia
lifestyle
polyamine
memory
elderly
prevention
treatment
dietary supplement
Polyamine-enriched diet
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany
name: Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria
First posted: 2016-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Cognitive Function (from neuropsychological test battery)
timeFrame: Prior to intervention (baseline) and after 3 months of intervention
Secondary outcomes:
measure: Laboratory parameters
timeFrame: Prior to intervention (baseline) and after 3 months of intervention
measure: Vascular parameters
timeFrame: Prior to intervention (baseline) and after 3 months of intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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