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

Charité University Medicine Berlin

Status and phase: Completed; Phase 2

Conditions: Subjective Cognitive Decline (SCD)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Polyamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03094546

SmartAge

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Polyamine supplementation

Experimental group

Description:

Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract

Treatment:

Dietary Supplement: Polyamine

Placebo

Placebo Comparator group

Description:

Intervention: Dietary Supplement Placebo: 750 mg cellulose

Treatment:

Dietary Supplement: Placebo