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

September 10, 2025 updated by: Brand's Suntory Asia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
276

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months
Florbetaben (18F) PET Scan Imaging
Time Frame: 24 months
Change from baseline values in Florbetaben (18F) PET scan
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: 12 months & 24 months
Change from baseline in handgrip strength
12 months & 24 months
Ratio of plasma tau protein and amyloid-beta 42
Time Frame: 24 months
Change from baseline in plasma tau protein & amyloid-beta 42 ratio
24 months
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.
12 months
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
12 months & 24 months
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.

  1. High-sensitivity C-reactive Protein (hs-CRP)
  2. Erythrocyte Sedimentation Rate (ESR)
  3. Tumor necrosis factor alpha (TNFα)
  4. Interleukin 6 (IL-6)
12 months & 24 months
Fasting blood glucose level
Time Frame: 4, 8, 12, 18 and 24 months
Change from baseline in fasting blood glucose level
4, 8, 12, 18 and 24 months
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.
4, 8, 12, 18 and 24 months
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.
4, 8, 12, 18 and 24 months
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.
4, 8, 12, 18 and 24 months
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
24 months, reported at each study visit (4, 8, 12, 18 and 24 months)
Cerebral blood flow measured with sonography
Time Frame: 12 months & 24 months
Mean values of cerebral blood flow measured with sonography
12 months & 24 months
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
4, 8, 12, 18 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brand's Suntory Asia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chang Gung Memorial Hospital
National Cheng-Kung University Hospital
Taipei Medical University Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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