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

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Charité University Medicine Berlin

Status and phase

Completed
Phase 2

Conditions

Subjective Cognitive Decline

Treatments

Dietary Supplement: Polyamine supplementation
Dietary Supplement: Placebo supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT02755246
preSmartAge

Details and patient eligibility

About

The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.

Full 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.

Enrollment

30 patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups, including a placebo group

Polyamine supplementation
Experimental group
Description:
750 mg polyamine-rich plant extract per day
Treatment:
Dietary Supplement: Polyamine supplementation
Placebo
Placebo Comparator group
Description:
750 mg potato starch per day
Treatment:
Dietary Supplement: Placebo supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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