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Completed

NCT Number: NCT04555655

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

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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Key information

Conditions

Cognitive Decline Aging Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Taipei Medical University Hospital Shuang Ho Hospital, New Taipei City, Taiwan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chicken extract supplement

Dietary Supplement

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

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.

Primary outcomes

  1. Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS)

    Time frame: 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.

  2. Florbetaben (18F) PET Scan Imaging

    Time frame: 24 months

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

Secondary outcomes

  1. Handgrip strength

    Time frame: 12 months & 24 months

    Change from baseline in handgrip strength

  2. Ratio of plasma tau protein and amyloid-beta 42

    Time frame: 24 months

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

  3. Alzheimer's Disease Composite Score (ADCOMS)

    Time frame: 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.

  4. Blood myeloperoxidase (MPO) levels

    Time frame: 12 months & 24 months

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

  5. Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, IL-6)

    Time frame: 12 months & 24 months

    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)

  6. Fasting blood glucose level

    Time frame: 4, 8, 12, 18 and 24 months

    Change from baseline in fasting blood glucose level

  7. Taiwanese Depression Questionnaire (TQD) score

    Time frame: 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.

  8. Short Form-36 (SF-36) Component and Scale Scores

    Time frame: 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.

  9. Athens Insomnia Scale (AIS)

    Time frame: 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.

  10. Incidence of infections

    Time frame: 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

  11. Cerebral blood flow measured with sonography

    Time frame: 12 months & 24 months

    Mean values of cerebral blood flow measured with sonography

  12. Blood pressure (systolic blood pressure and diastolic blood pressure)

    Time frame: 4, 8, 12, 18 and 24 months

    Change from baseline in systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Brand's Suntory Asia

Industry

Collaborators

  • Chang Gung Memorial Hospital
  • National Cheng-Kung University Hospital
  • Taipei Medical University Shuang Ho Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Sep 21, 2020
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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