F06.7
Conditions
Interventions
Group 1: Intervention:
Dietary Supplement: Spermidine Supplementation
Group 2: Placebo Comparator: Placebo Intake
Group 3: No Intervention: Healthy elderly controls (HC)
Sponsors
Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
55 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria (MCI patients): Men and women Written consent to participate in the study German at native speaker level Mild cognitive impairment (MCI) operationalized as: (a) A change in cognitive abilities reported by the patient, relatives or clinic staff (i.e. historical or observed evidence of deterioration over time)(b) Objective evidence of memory impairment (at least 1.0 Standard Deviation (SD) below the normal range on the Wechsler Logical Memory Scale (WMS-LM)); other cognitive domains may also be affected (i.e. amnestic MCI and amnestic + MCI)(c) Preservation of independence of functional abilities(d) No dementia Inclusion criteria (healthy controls): Men and women Written consent to participate in the study German at native speaker level Subjective cognitive disorders are denied
Exclusion criteria
Exclusion criteria: Exclusion Criteria (MCI patients): Patients who are unable to give informed consent Polyamine intake via dietary supplements and/or participation in corresponding intervention studies Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Any condition that impairs clinical or neuropsychological examination procedures Diabetes mellitus Polycystic ovary syndrome Signs of epilepsy, focal brain lesion or head injury with loss of consciousness or immediate post-injury confusion Previous stroke Severe untreated medical problems or unstable medical condition Current major depressive episode Psychotic disorder Bipolar disorder Current or previous substance abuse Other neurodegenerative disease, e.g. Parkinson's disease Vascular dementia Alcohol abuse Participation in an interventional study in the last 3 months and during the entire study period Sleep disorders Taking medication that primarily affects the central nervous system (e.g. antipsychotics, antidepressants, benzodiazepines or any type of over-the-counter sleep-inducing medication such as valerian; anti-dementia medication) Known intolerances or allergies to wheat germ, gluten or histamine Exclusion criteria (healthy controls): Subjects who are not able to give informed consent Polyamine intake via dietary supplements and/or participation in corresponding intervention studies Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Mild cognitive impairment (MCI), defined as described above in the patient inclusion criteria Any condition that interferes with clinical or neuropsychological examination procedures Diabetes mellitus Polycystic ovary syndrome Signs of epilepsy, focal brain lesion or head injury with loss of consciousness or immediate post-injury confusion Previous stroke Severe untreated medical problems or unstable medical condition Current major depressive episode Psychotic disorder Bipolar disorder Current or past substance abuse Other neurodegenerative disease, e.g. Parkinson's disease Vascular dementia Alcohol abuse Participation in an interventional study in the last 3 months and during the entire study period Sleep disorders Taking medication that primarily affects the central nervous system (e.g. antipsychotics, antidepressants, benzodiazepines or any type of over-the-counter sleep-inducing medication such as valerian; anti-dementia medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effects of spermidine supplementation on sleep quality as measured by electroencephalography (EEG) 2. Effects of spermidine supplementation on sleep-related memory consolidation as measured by cognitive computer tasks | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Differences in autophagy-related blood markers pre and post spermidine intervention in MCI as measured by polyamine concentration and eIF5A hypusination 4. Differences in neuropeptide blood levels pre and post spermidine intervention in MCI (mild cognitive impairment) 5. Differences in sleep parameters between MCI and healthy controls (HC) as measured by electroencephalography (EEG) 6. Differences in sleep-related memory consolidation between MCI and HC as measured by cognitive computer tasks 7. Differences in neuropeptide blood levels between MCI and HC 8. Differences in autophagy-related blood markers between MCI and HC as measured by polyamine concentration and eIF5A hypusination | — |
Countries
Germany
Contacts
Public ContactAgnes Flöel
Uniersitätsmedizin Greifswald
Outcome results
None listed