The Effects of Chicken Extract and a Peptide Supplement for the Prevention of Cognitive Decline in Non-demented Elderly Adults

Study Overview
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Brief Summary
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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.

Official Title
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Trial of A Chicken Extract and Peptide Supplement for the Prevention of Cognitive Decline and Mechanisms of Action in Non-demented Elderly Adults: A Multicenter, Two-year, Three-arm, Randomized, Double-blind, Placebo-controlled Study

Conditions
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Cognitive Decline, Mild Cognitive Impairment, Aging

Intervention / Treatment
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* Dietary Supplement: Chicken extract supplement
* Dietary Supplement: Peptide Supplement
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chicken extract supplement<br> | Dietary Supplement: Chicken extract supplement<br>* 70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years.<br>|
| Experimental: Peptides supplement<br> | Dietary Supplement: Peptide Supplement<br>* 70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. High-sensitivity C-reactive Protein (hs-CRP) Erythrocyte Sedimentation Rate (ESR) Tumor necrosis factor alpha (TNFα) Interleukin 6 (IL-6) | 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 |