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

NCT ID: NCT04555655

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2025-01-08

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.

Conditions

Cognitive Decline; Mild Cognitive Impairment; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Chicken extract supplement

Group Type: EXPERIMENTAL

Chicken extract supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Peptides supplement

Group Type: EXPERIMENTAL

Peptide Supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Chicken extract supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Peptide Supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Brand's Suntory Asia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University Hospital Shuang Ho Hospital

New Taipei City, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

BEC-CMI-003

Identifier Type: -

Identifier Source: org_study_id