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Cognitive DeclineEarly Phase 1NCT04555655

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

A Early Phase 1 study testing Chicken extract supplement and Peptide Supplement in people with Cognitive Decline and Mild Cognitive Impairment, run by Brand's Suntory Asia at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
What is being tested?
Chicken extract supplement and Peptide Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
3 sitesTaiwan
Study dates
11 Dec 2020to 8 Jan 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Taipei Medical University Hospital Shuang Ho Hospital

    New Taipei City, 235

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taoyuan Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official 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

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.

Being tested
Chicken extract supplement, Peptide Supplement, Placebo
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04555655
Study groupRoleWhat they receive
Chicken extract supplementExperimentalNot described
Receives: Dietary Supplement: Chicken extract supplement
Peptides supplementExperimentalNot described
Receives: Dietary Supplement: Peptide Supplement
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

  2. Florbetaben (18F) PET Scan Imaging

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

    Measured: 24 months

Secondary outcomes (12)

  1. Handgrip strength

    Change from baseline in handgrip strength

    Measured: 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

    Measured: 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.

    Measured: 12 months

  4. Blood myeloperoxidase (MPO) levels

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

    Measured: 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)

    Measured: 12 months & 24 months

  6. Fasting blood glucose level

    Change from baseline in fasting blood glucose level

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 12 months & 24 months

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

    Change from baseline in systolic and diastolic blood pressure

    Measured: 4, 8, 12, 18 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start11 Dec 2020
  3. Primary completion15 Nov 2024
  4. Study completion8 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04555655
Sponsor's protocol ID
BEC-CMI-003
Status last verified
Jan 2025
First submitted
3 Sep 2020
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Chicken extract supplement and Peptide Supplement in people with Cognitive Decline and Mild Cognitive Impairment, run by Brand's Suntory Asia at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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