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

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

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 Overview

• Status: Completed
• Conditions: Aging; Mild Cognitive Impairment; Cognitive Decline
• Intervention / Treatment: Dietary supplement: Chicken extract supplement; Dietary supplement: Peptide Supplement; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Taipei Medical University Hospital Shuang Ho Hospital
  • Tainan City, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taoyuan District, Taiwan, 333
    • Taoyuan Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brand's Suntory Asia
• Collaborators: Chang Gung Memorial Hospital; National Cheng-Kung University Hospital; Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): January 8, 2025

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: BEC-CMI-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No