Aging, Cognitive Decline, Mild Cognitive Impairment
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTChicken extract supplement
70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years.
DIETARY_SUPPLEMENTPeptide Supplement
70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.
OTHERPlacebo
70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.
Sponsors
Taipei Medical University Shuang Ho Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Brand's Suntory Asia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female at 55 - 75 years of age * Baseline cognition: * Normal cognition with feelings of cognitive decline (subjective cognitive decline) OR * Mild cognitive impairment (MCI+) with memory impairment * Agree to participate in the study and provide written informed consent
Exclusion criteria
* Inadequate visual and auditory acuity to allow neuropsychological testing * Significant cerebrovascular disease * History of allergy to chicken meat * Diagnosis of Alzheimer's disease (AD) with dementia or any other dementia * Clinical dementia rating (CDR) score of \> 0.5 at screening * Evidence of other neurological, psychiatric or physical illness that can produce cognitive deterioration per investigator's judgment * Inability or unwillingness to undergo PET scan * Current diagnosis or history of alcoholism or substance addiction * Regular use of any medication in the past 6 months that may affect cognitive functioning * Regular use of cognitive enhancing supplements in the past 6 months * Subjects with excessive blood donation or blood drawn prior to baseline * Persons with a history of cardiovascular disease or any other cardiovascular or cerebrovascular diseases which investigators deem unsuitable to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS) | 24 months | 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. |
| Florbetaben (18F) PET Scan Imaging | 24 months | Change from baseline values in Florbetaben (18F) PET scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | 12 months & 24 months | Change from baseline in handgrip strength |
| Ratio of plasma tau protein and amyloid-beta 42 | 24 months | Change from baseline in plasma tau protein & amyloid-beta 42 ratio |
| Alzheimer's Disease Composite Score (ADCOMS) | 12 months | 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. |
| Blood myeloperoxidase (MPO) levels | 12 months & 24 months | Change from baseline in blood myeloperoxidase (MPO) Higher levels of MPO indicate worse oxidative stress status |
| Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, IL-6) | 12 months & 24 months | Change from baseline in inflammation, measured by the following blood biomarkers. Each biomarker will be evaluated individually. 1. High-sensitivity C-reactive Protein (hs-CRP) 2. Erythrocyte Sedimentation Rate (ESR) 3. Tumor necrosis factor alpha (TNFα) 4. Interleukin 6 (IL-6) |
| Fasting blood glucose level | 4, 8, 12, 18 and 24 months | Change from baseline in fasting blood glucose level |
| Taiwanese Depression Questionnaire (TQD) score | 4, 8, 12, 18 and 24 months | 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. |
| Short Form-36 (SF-36) Component and Scale Scores | 4, 8, 12, 18 and 24 months | 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. |
| Athens Insomnia Scale (AIS) | 4, 8, 12, 18 and 24 months | 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. |
| Incidence of infections | 24 months, reported at each study visit (4, 8, 12, 18 and 24 months) | Number and incidence of infections occurring during the study period according to a self-reported infection survey |
| Cerebral blood flow measured with sonography | 12 months & 24 months | Mean values of cerebral blood flow measured with sonography |
| Blood pressure (systolic blood pressure and diastolic blood pressure) | 4, 8, 12, 18 and 24 months | Change from baseline in systolic and diastolic blood pressure |
Countries
Taiwan
Outcome results
None listed