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Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline (SmartAge)

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ClinicalTrials.gov Identifier: NCT03094546
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
Freie Universität, Institute of Biology/Genetic, Berlin, Germany
Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria
Information provided by (Responsible Party):
Claudia Schwarz, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE March 14, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date April 26, 2021
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)		 Change in Memory performance from neuropsychological test [ Time Frame: change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months) ]
Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • Change in Cognitive Function (from extended neuropsychological test battery) [ Time Frame: change from baseline after 12 month ]
    Comparing cognitive function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention
  • Change in polyamine concentration [ Time Frame: change from baseline after 12 month ]
    comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
  • Change in inflammation [ Time Frame: change from baseline after 12 month ]
    comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
  • Change in Brain imaging biomarkers [ Time Frame: change from baseline after 12 month ]
    Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging
  • Change in Autophagy processes [ Time Frame: change from baseline after 12 month ]
    Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention
  • Change in Autophagy processes [ Time Frame: change from baseline after 12 month ]
    Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline
Official Title  ICMJE Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline
Brief Summary 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 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Subjective Cognitive Decline (SCD)
Intervention  ICMJE
  • Dietary Supplement: Polyamine
    12 months of polyamine supplementation (6 capsules/day)
  • Dietary Supplement: Placebo
    12 months of placebo intake (6 capsules/day)
Study Arms  ICMJE
  • Experimental: Polyamine supplementation
    Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract
    Intervention: Dietary Supplement: Polyamine
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement Placebo: 750 mg cellulose
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)		 100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2020
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03094546
Other Study ID Numbers  ICMJE SmartAge
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Claudia Schwarz, Charite University, Berlin, Germany
Original Responsible Party Agnes Flöel, Charite University, Berlin, Germany, Prof. Agnes Flöel, MD;
Current Study Sponsor  ICMJE Charite University, Berlin, Germany
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Freie Universität, Institute of Biology/Genetic, Berlin, Germany
  • Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria
Investigators  ICMJE
Principal Investigator: Agnes Floeel, Prof Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin
Principal Investigator: Dietmar Schmitz, Prof Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP