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

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

Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function 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.

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 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 Type

Interventional

Enrollment (Actual)

30

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
        • Charite Universitatsmedizin Berlin

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Prior to intervention (baseline) and after 3 months of intervention

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Collaborators

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

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

April 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 28, 2016

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

  • preSmartAge

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.

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