CClinicalTrials.gg
CompletedNCT04555655Updated Sep 16, 2025

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

An Early Phase 1 interventional study of Chicken extract supplement and Peptide Supplement in Cognitive Decline, Mild Cognitive Impairment and Aging, sponsored by Brand's Suntory Asia. Completed at 3 sites in Taiwan. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Brand's Suntory Asia · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cognitive Decline
  • Mild Cognitive Impairment
  • Aging
03

In context

Cognitive Dysfunction

3,842 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.

This study's enrollment of 276 is above the median of 65 across 2,807 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Brand's Suntory Asia is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
276 participants (actual)

Study arms

  • Experimental
    Chicken extract supplement

    Dietary Supplement: Chicken extract supplement

  • Experimental
    Peptides supplement

    Dietary Supplement: Peptide Supplement

  • Placebo comparator
    Placebo

    Other: Placebo

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. Florbetaben (18F) PET Scan Imaging

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

    Time frame: 24 months

Secondary outcomes

  1. Handgrip strength

    Change from baseline in handgrip strength

    Time frame: 12 months & 24 months

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

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

    Time frame: 24 months

  3. 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: 12 months

  4. 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

  5. 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)

    Time frame: 12 months & 24 months

  6. Fasting blood glucose level

    Change from baseline in fasting blood glucose level

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. Incidence of infections

    Number and incidence of infections occurring during the study period according to a self-reported infection survey

    Time frame: 24 months, reported at each study visit (4, 8, 12, 18 and 24 months)

  11. Cerebral blood flow measured with sonography

    Mean values of cerebral blood flow measured with sonography

    Time frame: 12 months & 24 months

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

    Change from baseline in systolic and diastolic blood pressure

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

07

Study locations

3 sites
  • Taipei Medical University Hospital Shuang Ho Hospital
    New Taipei City, 235, Taiwan
  • National Cheng Kung University Hospital
    Tainan, 704, Taiwan
  • Taoyuan Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04555655
Lead sponsor
Brand's Suntory Asia
Collaborators
Taipei Medical University Shuang Ho Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Sep 21, 2020
Start date
Dec 11, 2020
Primary completion
Nov 15, 2024
Completion
Jan 8, 2025
Last update
Sep 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion