Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline

Charite University, Berlin, Germany100 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Subjective Cognitive Decline (SCD)

Interventions

PolyamineDIETARY_SUPPLEMENT

12 months of polyamine supplementation (6 capsules/day)

PlaceboDIETARY_SUPPLEMENT

12 months of placebo intake (6 capsules/day)

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 * Drug abuse or alcohol dependency * Current polyamine substitution

Locations (1)

Charité University Medicine Berlin, CCM, Department of Neurology,

Berlin, Germany

Outcomes

Primary Outcomes

Change in Memory performance from neuropsychological test

Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention

Time frame: change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months)

Secondary Outcomes

Change in Cognitive Function (from extended neuropsychological test battery)

Comparing cognitive function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention