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

Study Overview
=================
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.

Official Title
-----------------
Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function in Healthy Older Adults With Subjective Cognitive Decline

Conditions
-----------------
Subjective Cognitive Decline

Intervention / Treatment
-----------------
* Dietary Supplement: Polyamine supplementation
* Dietary Supplement: Placebo supplementation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyamine supplementation<br>750 mg polyamine-rich plant extract per day | Dietary Supplement: Polyamine supplementation<br>* 3 months of polyamine supplementation (3 capsules/day)<br>|
| Placebo Comparator: Placebo<br>750 mg potato starch per day | Dietary Supplement: Placebo supplementation<br>* 3 months of placebo intake (3 capsules/day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Function (from neuropsychological test battery) | Comparing changes in cognitive function in subjects with polyamine intake and placebo treatment (pre vs. post intervention) | Prior to intervention (baseline) and after 3 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory parameters | comparing different markers derived from blood plasma like polyamine concentration (spermine, spermidine) and markers of inflammation pre vs. post intervention | Prior to intervention (baseline) and after 3 months of intervention | 
| Vascular parameters | Comparing intima-media-thickness pre vs. post intervention | Prior to intervention (baseline) and after 3 months of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subjective cognitive decline, dementia, lifestyle, polyamine, memory, elderly, prevention, treatment, dietary supplement, Polyamine-enriched diet