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

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ClinicalTrials.gov Identifier: NCT02755246
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany
Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria
Information provided by (Responsible Party):
Claudia Schwarz, Charite University, Berlin, Germany

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subjective Cognitive Decline Dietary Supplement: Polyamine supplementation Dietary Supplement: Placebo supplementation Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function in Healthy Older Adults With Subjective Cognitive Decline
Study Start Date : April 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Polyamine supplementation
750 mg polyamine-rich plant extract per day
 Dietary Supplement: Polyamine supplementation
3 months of polyamine supplementation (3 capsules/day)
Placebo Comparator: Placebo
750 mg potato starch per day
 Dietary Supplement: Placebo supplementation
3 months of placebo intake (3 capsules/day)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755246


Locations
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Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany
Karl-Franzens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria
Investigators
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Principal Investigator: Agnes Flöel, Prof. Dr. Charite University, Berlin, Germany
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Claudia Schwarz, Postdoctoral Researcher, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02755246    
Other Study ID Numbers: preSmartAge
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Keywords provided by Claudia Schwarz, Charite University, Berlin, Germany:
subjective cognitive decline
dementia
lifestyle
polyamine
memory
 elderly
prevention
treatment
dietary supplement
Polyamine-enriched diet
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders