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

This study has been completed.
Sponsor:
Collaborators:
Charité Universitätsmedizin, NeuroCure, Berlin, Germany
Freie Universität Berlin, Institute of Biology/Genetic, Berlin,Germany
Karl-Fransens-Universität Graz, Institute of Molecular Biosciences, Graz, Austria
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02755246
First received: April 5, 2016
Last updated: December 21, 2016
Last verified: December 2016
  Purpose
The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.

Condition Intervention Phase
Subjective Cognitive Decline
Dietary Supplement: Polyamine supplementation
Dietary Supplement: Placebo supplementation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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:
  • 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

  • Vascular parameters [ Time Frame: Prior to intervention (baseline) and after 3 months of intervention ]
    Comparing intima-media-thickness pre vs. post intervention


Enrollment: 30
Study Start Date: April 2016
Study Completion Date: September 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polyamine supplementation Dietary Supplement: Polyamine supplementation
3 months of polyamine supplementation (3 capsules/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo supplementation
3 months of placebo intake (3 capsules/day)

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.
  Eligibility

Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02755246

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

Additional Information:
Publications:

Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02755246     History of Changes
Other Study ID Numbers: preSmartAge
Study First Received: April 5, 2016
Last Updated: December 21, 2016

Keywords provided by Charite University, Berlin, Germany:
subjective cognitive decline
dementia
lifestyle
polyamine
memory
elderly
prevention
treatment
dietary supplement
Polyamine-enriched diet

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 23, 2017