Polyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline

Phase 2

Completed

• Conditions: Subjective Cognitive Decline
• Interventions: Dietary Supplement: Polyamine supplementation; Dietary Supplement: Placebo supplementation

• Registration Number: NCT02755246
• 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 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-28
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyamine supplementation	Polyamine supplementation	750 mg polyamine-rich plant extract per day
Placebo	Placebo supplementation	750 mg potato starch per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Vascular parameters	Prior to intervention (baseline) and after 3 months of intervention	Comparing intima-media-thickness pre vs. post intervention
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

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany