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Completed

NCT Number: NCT02755246

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

The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.

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Key information

Conditions

Subjective Cognitive Decline Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyamine supplementation

Dietary Supplement

3 months of polyamine supplementation (3 capsules/day)

Placebo supplementation

Dietary Supplement

3 months of placebo intake (3 capsules/day)

Primary outcomes

  1. Change in Cognitive Function (from neuropsychological test battery)

    Time frame: 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 outcomes

  1. Laboratory parameters

    Time frame: 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

  2. Vascular parameters

    Time frame: Prior to intervention (baseline) and after 3 months of intervention

    Comparing intima-media-thickness pre vs. post intervention

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Freie Universität Berlin
  • Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria

Registry information

Official study title

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

Acronym: preSmartAge

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2016
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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