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

Early Phase 1

Completed

• Conditions: Mild Cognitive Impairment; Cognitive Decline; Aging
• Interventions: Other: Placebo; Dietary Supplement: Chicken extract supplement; Dietary Supplement: Peptide Supplement

• Registration Number: NCT04555655
• Lead Sponsor: Brand's Suntory Asia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2020-12-11
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Chicken extract supplement	Chicken extract supplement	-
Peptides supplement	Peptide Supplement	-

Primary Outcome Measures

Name	Time	Method
Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS)	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.
Florbetaben (18F) PET Scan Imaging	24 months	Change from baseline values in Florbetaben (18F) PET scan

Secondary Outcome Measures

Name	Time	Method
Athens Insomnia Scale (AIS)	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.
Incidence of infections	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
Cerebral blood flow measured with sonography	12 months & 24 months	Mean values of cerebral blood flow measured with sonography
Handgrip strength	12 months & 24 months	Change from baseline in handgrip strength
Ratio of plasma tau protein and amyloid-beta 42	24 months	Change from baseline in plasma tau protein \& amyloid-beta 42 ratio
Taiwanese Depression Questionnaire (TQD) score	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.
Blood pressure (systolic blood pressure and diastolic blood pressure)	4, 8, 12, 18 and 24 months	Change from baseline in systolic and diastolic blood pressure
Blood myeloperoxidase (MPO) levels	12 months & 24 months	Change from baseline in blood myeloperoxidase (MPO) Higher levels of MPO indicate worse oxidative stress status
Fasting blood glucose level	4, 8, 12, 18 and 24 months	Change from baseline in fasting blood glucose level
Alzheimer's Disease Composite Score (ADCOMS)	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.
Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, IL-6)	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)
Short Form-36 (SF-36) Component and Scale Scores	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.

Trial Locations

Locations (3)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Taoyuan Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

Taipei Medical University Hospital Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan