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

April 22, 2021 updated by: Claudia Schwarz, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité University Medicine Berlin, CCM, Department of Neurology,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyamine supplementation
Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract
Dietary supplement: Polyamine
12 months of polyamine supplementation (6 capsules/day)
Placebo Comparator: Placebo
Intervention: Dietary Supplement Placebo: 750 mg cellulose
Dietary supplement: Placebo
12 months of placebo intake (6 capsules/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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 from baseline after 12 month
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 from baseline after 12 month
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 from baseline after 12 month
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 from baseline after 12 month
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 from baseline after 12 month
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
change from baseline after 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Freie Universität, Institute of Biology/Genetic, Berlin, Germany
Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria

Investigators

  • Principal Investigator: Agnes Floeel, Prof, Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin
  • Principal Investigator: Dietmar Schmitz, Prof, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SmartAge

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subjective Cognitive Decline (SCD)

Clinical Trials on Polyamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe