Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline

Conditions
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Subjective Cognitive Decline (SCD)

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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>Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract | Dietary Supplement: Polyamine<br>* 12 months of polyamine supplementation (6 capsules/day)<br>|
| Placebo Comparator: Placebo<br>Intervention: Dietary Supplement Placebo: 750 mg cellulose | Dietary Supplement: Placebo<br>* 12 months of placebo intake (6 capsules/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | change from baseline after 12 month | 
| Change in polyamine concentration | comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month | 
| Change in inflammation | comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month | 
| Change in Brain imaging biomarkers | Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging | change from baseline after 12 month | 
| Change in Autophagy processes | Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month | 
| Change in Autophagy processes | Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjective cognitive decline, polyamine, Alzheimer's disease, dementia, dietary supplement, prevention, treatment, lifestyle, memory, autophagy