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| Name | Class |
|---|---|
| Taipei Medical University Shuang Ho Hospital | OTHER |
| National Cheng-Kung University Hospital | OTHER |
| Chang Gung Memorial Hospital | OTHER |
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This trial investigates the effect of a chicken extract supplement and a peptide supplement on cognitive function and potential mechanisms of action of cognitive decline during ageing, among non-demented elderly adults using a three-arm, randomized, placebo-controlled clinical trial design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chicken extract supplement | Experimental |
| |
| Peptides supplement | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chicken extract supplement | Dietary Supplement | 70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS) | Change from baseline in Alzheimer's Disease Composite Score (ADCOMS). ADCOMS composite score is a weighted linear combination of the 12 items in the Wold's partial least squares (PLS) model. Composite scores range from 0.0 to a maximum of 1.97, where higher values indicate worse performance. | 24 months |
| Florbetaben (18F) PET Scan Imaging | Change from baseline values in Florbetaben (18F) PET scan | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength | Change from baseline in handgrip strength | 12 months & 24 months |
| Ratio of plasma tau protein and amyloid-beta 42 | Change from baseline in plasma tau protein & amyloid-beta 42 ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital Shuang Ho Hospital | New Taipei City | 235 | Taiwan | |||
| National Cheng Kung University Hospital |
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| Peptide Supplement | Dietary Supplement | 70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years. |
|
| Placebo | Other | 70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years. |
|
| 24 months |
| Alzheimer's Disease Composite Score (ADCOMS) | Change from baseline in Alzheimer's Disease Composite Score (ADCOMS). ADCOMS composite score is a weighted linear combination of the 12 items in the Wold's partial least squares (PLS) model. Composite scores range from 0.0 to a maximum of 1.97, where higher values indicate worse performance. | 12 months |
| Blood myeloperoxidase (MPO) levels | Change from baseline in blood myeloperoxidase (MPO) Higher levels of MPO indicate worse oxidative stress status | 12 months & 24 months |
| Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, IL-6) | Change from baseline in inflammation, measured by the following blood biomarkers. Each biomarker will be evaluated individually.
| 12 months & 24 months |
| Fasting blood glucose level | Change from baseline in fasting blood glucose level | 4, 8, 12, 18 and 24 months |
| Taiwanese Depression Questionnaire (TQD) score | Change from baseline in patient-reported Taiwanese Depression Questionnaire (TQD) scores. TDQ scores range from 0 to 54, with the higher score indicating the greater depression state. | 4, 8, 12, 18 and 24 months |
| Short Form-36 (SF-36) Component and Scale Scores | Change from baseline in Short Form-36 (SF-36) Component and Scale Scores. Each scale is directly transformed into a 0 - 100 scale on the assumption that each question carries equal weight. Lower score indicates more disability/worse health status. | 4, 8, 12, 18 and 24 months |
| Athens Insomnia Scale (AIS) | Change from baseline in Athens Insomnia Scale Score. A composite score which ranges from 0-24 will be evaluated. Higher score stands for greater severity of insomnia. | 4, 8, 12, 18 and 24 months |
| Incidence of infections | Number and incidence of infections occurring during the study period according to a self-reported infection survey | 24 months, reported at each study visit (4, 8, 12, 18 and 24 months) |
| Cerebral blood flow measured with sonography | Mean values of cerebral blood flow measured with sonography | 12 months & 24 months |
| Blood pressure (systolic blood pressure and diastolic blood pressure) | Change from baseline in systolic and diastolic blood pressure | 4, 8, 12, 18 and 24 months |
| Tainan |
| 704 |
| Taiwan |
| Taoyuan Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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