NCT04555655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2020

Longer than P75 for early_phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 11, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2025

Completed
Last Updated

September 16, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

September 3, 2020

Last Update Submit

September 10, 2025

Conditions

Cognitive DeclineMild Cognitive ImpairmentAging

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Handgrip strength

    12 months & 24 months

  • Ratio of plasma tau protein and amyloid-beta 42

    24 months

  • Alzheimer's Disease Composite Score (ADCOMS)

    12 months

  • Blood myeloperoxidase (MPO) levels

    12 months & 24 months

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

    12 months & 24 months

  • +7 more secondary outcomes

Study Arms (3)

Chicken extract supplement

EXPERIMENTAL
Dietary Supplement: Chicken extract supplement

Peptides supplement

EXPERIMENTAL
Dietary Supplement: Peptide Supplement

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Chicken extract supplementDIETARY_SUPPLEMENT

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

Chicken extract supplement
Peptide SupplementDIETARY_SUPPLEMENT

70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.

Peptides supplement
PlaceboOTHER

70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.

Placebo

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Taipei Medical University Hospital Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 21, 2020

Study Start

December 11, 2020

Primary Completion

November 15, 2024

Study Completion

January 8, 2025

Last Updated

September 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)