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

Early Phase 1CompletedNCT04555655

Brand's Suntory Asia276 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

276

Conditions

Cognitive Decline Mild Cognitive Impairment Aging

Interventions

Chicken extract supplementDIETARY_SUPPLEMENT

70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years.

Peptide SupplementDIETARY_SUPPLEMENT

70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.

PlaceboOTHER

70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Taipei Medical University Hospital Shuang Ho Hospital

New Taipei City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Florbetaben (18F) PET Scan Imaging

Change from baseline values in Florbetaben (18F) PET scan

Time frame: 24 months

Secondary Outcomes

Handgrip strength

Change from baseline in handgrip strength

Time frame: 12 months & 24 months

Ratio of plasma tau protein and amyloid-beta 42

Change from baseline in plasma tau protein \& amyloid-beta 42 ratio

Time frame: 24 months

Alzheimer's Disease Composite Score (ADCOMS)

Time frame: 12 months

Blood myeloperoxidase (MPO) levels

Change from baseline in blood myeloperoxidase (MPO) Higher levels of MPO indicate worse oxidative stress status

Time frame: 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. 1. High-sensitivity C-reactive Protein (hs-CRP) 2. Erythrocyte Sedimentation Rate (ESR) 3. Tumor necrosis factor alpha (TNFα) 4. Interleukin 6 (IL-6)

Data from ClinicalTrials.gov

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